Q1 2022 Omeros Corp Earnings Call
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Today's conference is scheduled to begin shortly please continue to standby and thank you for your patience.
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Good afternoon, and welcome to today's earnings call for.
Romero Corporation at this time, all participants are in listen only mode. After the company's remarks, we will conduct a question and answer session. Please be advised that this call is being recorded at the company's request and a replay will be available on the company's website.
For one week from today.
I'll now turn the call over to Jennifer Williams Investor Relations for <unk>.
Good afternoon, and thank you for joining the call today I'd like to remind you that some of the statements that will be made on the call today will be forward. Looking these statements are based on management's beliefs and expectations as of today only and are subject to change all forward looking statements involve risks and uncertainties that could cause the company's actual results to differ materially.
Please refer to the special note regarding forward looking statements and the risk factors section in the company's quarterly report on Form 10-Q, which was filed today with the SEC and the risk factors section of the company's 2021 annual report on Form 10-K for a discussion of these risks and uncertainties.
Now I would like to turn the call over to Dr. Greg Demopoulos, Chairman and CEO of Americas.
Thank you Jennifer and good afternoon, everyone. We appreciate you joining us for today's call.
We will start with a corporate update and an overview of our first quarter 2022 financial results followed by a more detailed financial summary, joining me on the call today are Mike Jacobsen Nordea dock, Cathy Melfi, and Steven Whittaker, our respective heads of finance commercial regulatory and clinical.
<unk>.
Let's begin with our mast two program and specifically <unk> and stem cell transplant associated thrombotic microangiopathy or Ta TMA.
In February we had a type a post action meeting with F. D. A following receipt of our complete response letter.
And our briefing package and during the meeting we addressed all of Fda's stated concerns.
The FDA was delayed and providing their final meeting minutes to us when we finally received them there were no new requests.
We found that the division had repeated a number of critics.
That we feel has not only been adequately addressed but also something that we view as demonstrably inaccurate based on fda's own minutes and other official communications.
After close review and discussions with our legal and regulatory advisors, we began drafting a dispute resolution request.
An official F D. A pathway that allows the sponsor to appeal the decision by an FDA division too.
A higher deciding authority and the agency in this case the office of new drugs.
With the assistance of our legal and regulatory advisors, including recent former FDA office and Division directors.
We are now completing the draft request, we believe that it lays out a very strong case across all components of our data.
The documented regulatory history, not only F D a precedent, but precedent established by our specific division.
And the literature.
Now that the document is drafted and we have assessed the strengths of both our position and the document our path forward is clear.
Based on the strength of our case and on the input and recommendation of our legal and regulatory advisors. We are foregoing negotiation with the division and preceding directly to dispute resolution.
We believe that this is the most expeditious route to approval.
Dispute resolution by design is rapid.
Our request is clear.
And that is regular approval based on the data and our existing BLA.
With respect to timing, we are incorporating comments from our advisors and have begun the process of regulatory publishing required prior to submission.
We expect to submit within the next couple of weeks.
We are requesting a meeting with the office of new drugs that meeting according to FDA as Purdue for commitments should be held within 30 days of the request.
A decision is then to be rendered within 30 days following the meeting.
Although public statistics indicate that most appeals are denied those statistics are misleading.
And the collective experience of our advisors at both Covington and Burling in Heinemann Philips Mcnamara. The good majority of their appeals, even if formally denied.
Salt and a favorable outcome for the sponsor.
We are confident in our data and in our submission we.
We believe that in our supplemental should've been approved last fall and we are committed to getting it approved as quickly as possible.
In the meantime, transplant or continue requesting in our supplement under our compassionate use program.
For their patients with Ta TMA and.
And we make every attempt to provide it especially for children.
Two recent examples include two seven year old Little girls, one in Italy, and the other in Australia, One who had failed defib retired and the other had failed both <unk> and <unk>.
Within our supplemental treatment both children have recovered and have been able to return home.
The results from our in our supplement a pivotal trial in Ta TMA were recently published in the journal of clinical oncology or J C. O. One of the Premier medical journals in the flagship publication of the American Society of clinical oncology.
Authored by a group of leading international transplants, a manuscript was published online by J C. O. A few days prior to the start of tandem 2022.
Held this year in Salt Lake City, the tandem conferences comprised the joint annual meetings of the American Society for transplantation, and cellular therapy or TCT.
And the center for international Blood and marrow transplant research.
As part of the conference <unk> received an award from the President of a S. T. C T crediting home barrels for our work in raising awareness of Ta TMA and advancing the medical and scientific understanding in the field.
The keen interest in our supplement was palpable among physicians pharmacists nurses and patient advocacy groups and attendance at the meeting.
Underscored by the number of times, our newly published manuscript was downloaded from the <unk> website.
More than 2000 times during the first week of availability and more than 3000 times only two short weeks since the tandem conference.
In March at the European Society for blood and marrow transplantation or E. BMT important aspects of Ta TMA and our <unk> were presented.
One presentation reported on a rigorous literature review of the natural history of high risk Ta TMA.
Which is the same patient population enrolled in our supplement <unk> pivotal trial.
And the literature review patients who received only supportive measures had just a 23% response rate even though the definition of response for the literature review was less stringent than that used in our supplement a pivotal trial.
Just to refresh your memory in that pivotal trial will merrill's found a 61% response rate in our supplement.
Another <unk> presentation was a case report on a nine month old girl at Emory University, who had failed treatment with <unk>, whose life. The investigator believes was saved by in our supplement.
All of this on our merits along with the community of physicians patients and caregivers searching for an effective therapy for Ta TMA look forward to wider availability of in our supplement following regulatory approval.
And we expect that we will get there.
R&R supplemented by Jane Nephropathy program also has made good progress enrollment in our phase III Artemis <unk> trial has accelerated and we continue to target reading out nine months data on proteinuria in the first half of next year.
The trial is assessing both an overall population of <unk> patients with baseline proteinuria greater than or equal to one gram per day.
And a population of patients with more severe disease, whose baseline proteinuria is at least two grams of proteinuria per day.
The trial is designed so that either population can support accelerated or regular approval.
Our <unk> efforts in China are also proving successful our investigational new drug application for <unk> was approved in China, and we look forward to completing the few remaining regulatory requirements and initiating enrollment there as soon as possible.
Our phase III, our supplemental trial in patients with AA U S. Also is ongoing although as previously reported this program has been de prioritized relative to our other master II in math degree programs.
<unk> is also being evaluated for the treatment of hospitalized COVID-19 patients in the <unk> platform trials sponsored by quantum leaf healthcare collaborative.
The trial has evaluated multiple drugs as potential COVID-19 therapeutics and to date, none have been publicly reported to show a benefit relative to the background therapy in the trial.
We are limited in what we can say about the trial per our agreement with quantum.
We can confirm.
Though that in the latter part of last year.
Concurrent with stopping enrollment and in our supplemental treatment arm quantum initiated discussions regarding.
Additional clinical work focused on our supplemental for various reasons that study did not go forward.
We would very much like to report the data to date and are working collaboratively with quantum to finalize analysis.
As soon as we can we all look forward to sharing the outcome of the trial.
Meanwhile, work at the Maryland, Cambridge Center for complement in inflammation researcher Oc three IR continues to provide important contributions to the fields understanding of the mechanism of <unk> and the pathophysiology of COVID-19.
A manuscript by Lee at all published last month in Frontiers in immunology detailed the secondary infection in COVID-19.
A significant cause of morbidity and mortality in Covid is.
Is driven by complement hyperactive activation.
Most likely lectin pathway hyperactivity.
A second manuscript.
Delayed to include additional new data.
Has now been submitted for publication and demonstrates that in fact, it is hyper activation of the lectin pathway that causes complement dysfunction in acute severe COVID-19 and that in our supplement rapidly normalizes complement function restore.
Restoring the bodies infection fighting ability.
As more and more research from groups around the world as published demonstrating the importance of complement and COVID-19, and specifically the central role of the lectin pathway.
Interest continues to increase in our <unk> as a treatment for acute severe COVID-19 and also potentially.
As prevention or treatment of long COVID-19 or pasque.
This has resulted in receptive discussions with Biden administration, COVID-19 advisors and principles at NIH.
Our team continues to advance research in both acute severe and long COVID-19.
With respect to lifecycle management for our mass II program O M. S 10, 29, our long acting second generation masked two antibody is advancing quickly.
Having successfully completed non clinical toxicology studies without a safety signal of concern.
The phase one trial is planned to begin this summer with.
With expected dosing in humans of once monthly two even once quarterly <unk>.
<unk> 10, 29 allows us to pursue a range of indications complementary to those of our supplement.
We've also made good progress on our small molecule mass two inhibitors designed for oral administration.
And we're driving to advance a lead oral candidate to the clinic as soon as possible.
Let's now turn to Omidria as we discussed on our year end earnings call Omidria completed the strategic divestiture.
To Rainer surgical last December the <unk>.
Transaction with Rainer required us to classify.
All historical Omidria revenue and expenses into discontinued operations as well as to record the royalties, we earn as a reduction of the omidria contract royalty asset on our balance sheet.
Our royalty rate for U S. Net sales of Omidria is 50%.
Given the required reclassification of Omidria revenues and expenses.
Our revenues for the first quarter were reported as zero and.
And our net loss from continuing operations recorded as $35 million compared to $45 $3 million in the prior year quarter.
Our overall loss for the current quarter was $33 million or <unk> 53 per share compared to $35 $1 million or <unk> 57 per share in the first quarter of last year.
Our noncash expenses were $4 2 million or seven cents per share.
Compared to.
The same quarter last year of $4 $1 million.07 per share.
In total our change in cash and investments from year end was a decrease of $15 million.
Rainer reported Omidria net sales of $27 $8 million for the first quarter.
This represents an approximately 31% increase over the $21 $1 million of sales for the first quarter of 2021.
As I mentioned, we earn royalties at 50% of Rainer net sales, which translates to $13.8 million.
As discussed in prior calls when considering the royalty we receive and the reduction in our operating cost we retain approximately 70% of the Omidria operating profit when royalties are at 50% of Omidria net sales.
During the quarter, we worked closely with Rainer to help ensure a smooth transition of the product the teams and all operations with minimal disruption to customers.
By all indications that transition has gone very well.
The first quarter typically has the lowest quarter for cataract procedure volume and as a consequence has historically been the weakest for Omidria sales and.
And we expect Omidria revenues to continue to grow.
As of March 31, 2022, we had $142 $2 million of cash and investments on hand.
Available to support ongoing operations.
As previously noted this is a decrease of $15 million from December 31 2021.
We also have $16 3 million of receivables, primarily omidria royalties related to the first quarter, which will be collected this month.
Going forward.
Imagery of royalties will be paid monthly within 60 days of being earned and.
In addition, we have a $150 million at the market sales agreement, which we have not used.
Also under the terms of the range transaction <unk> is eligible to receive a $200 million milestone if before 2025 separate payment for Omidria is secured for a continuous period of at least four years.
One vehicle through which the $200 million milestone could be achieved as the enactment of the no pain Act, which has been introduced in both chambers of commerce.
And would provide separate payment for renewable period of five years.
For non opioid pain management drugs like Omidria in ambulatory surgery centers or <unk> as well as in hospital outpatient departments or H O P DS.
Currently CMS pay separately for Omidria in the ASC is only.
So the enactment of no pain would expand separate payment to H O P DS as well.
Efforts to advance the no pain act are being led nationally by voices for non opioid choices.
And the legislation has been endorsed by more than 80 major medical societies patient advocacy groups and prevention and recovery organizations across the country.
The legislation is good policy.
And enjoys strong bipartisan and bicameral support in Congress with sponsors and cosponsors now numbering 48 Senators and 99 Representatives. Most recently the 98 member New Democratic Coalition, one of the largest and most influential caucus.
And the house of Representatives has.
Has endorsed the no pain act, making it a key part of the coalition's legislative agenda for this summer.
So wrapping up with the divestiture of Omidria, we have a passive but substantial funding source to help finance <unk> biotech portfolio.
Which is focused on immunology, including what many believe is the premier complement franchise in the industry.
And our novel immuno oncology programs and on addiction.
Having already discussed in our supplemental and our mast two program, let's move now to almost 906, our antibody targeting <unk> three.
<unk> three is the key activator of the alternative pathway of complement.
After having received scientific advice from the UK Health Authority NHRA.
We submitted our clinical trial application and remain on schedule.
To initiate a phase one b trial this summer.
The trial will evaluate <unk> nine O six in patients with paroxysmal nocturnal hemoglobinuria or <unk>, who have an unsatisfactory response to the C. Five inhibitor raviolis amount.
We previously completed a phase one study in healthy subjects and results showed high levels suppression of alternative pathway activity.
Favorable pharmacokinetics and a good safety profile.
While there can be no guarantees based on well documented mechanism of action animal data and our phase one results. We expect that all M. S 906 will be effective in <unk>.
Addressing both intra vascular and extra vascular hemolysis.
We and others in the industry regard mass III as the premier drug target in the alternative pathway.
And expect that O M. S. Nine O six will have significant advantages over other agents on the market or in development to treat <unk>.
Those potential advantages include one efficacy on.
Unlike C. Five inhibitors on S. 906 is expected to inhibit intravascular and to prevent extra vascular red blood cell destruction.
Two safety.
Unlike other agents on the market for Pn H O M. S. 906 has been shown to leave intact. The infection fighting ability of the adaptive immune response.
Three dosing.
Unlike factor <unk> three inhibitors, which are currently dose twice daily or twice weekly <unk>.
900, <unk> is planned for once monthly two once quarterly administration.
And finally.
Other drugs in the complement system's alternative pathway are what are referred to as acute phase reactants, meaning that the blood concentration of those targets fluctuate substantially with inflammation.
This can make dosing drugs and interact with those targets challenging leading to under or overdosing.
To the best of our knowledge mask three is not an acute phase reactants, meaning that the dosing of O M. S 906 can be more precise.
We look forward to beginning dosing in <unk> patients soon.
Turning now to all of them as five to seven given the resource constraints, we've prioritized our complement clinical programs over those of our phosphodiesterase seven or <unk> inhibitor program.
We previously successfully completed a phase one study of the lead molecule in this program.
Discussions are underway regarding securing third party funding for continued development of all of them as five to seven.
We're also exploring the potential of our PD <unk> inhibitors to improve dyskinesia and parkinsons disease more than 50% of Parkinson's patients develop L. Dopa induced dyskinesia following prolonged L dopa treatment and.
In collaboration with Emory University, we're evaluating our compounds and irrelevant primate Parkinson's disease models.
We have previously shown that the <unk> seven inhibitors improve outcomes and models of Parkinson's through modulation of the dopaminergic system and we've established a broad intellectual property estate covering the use of PD one inhibitors.
For not only that.
Treatment of addiction, and compulsive disorders, but for the treatment of motor disorders, including Parkinson's disease.
Finally, let's turn now to our immuno oncology programs.
We've continued to focus on methods to improve the effectiveness of current cancer therapies.
<unk> hundred 74 is one of the 54 orphan G protein coupled receptors or <unk> that we have unlocked in our GPC our platform and.
And we continue to explore modulators of the GPI 174 receptor as a means of significantly improving the tumor killing effects of current therapies.
<unk> adenosine pathway inhibitors and checkpoint inhibitors.
Additionally, we are advancing research on technology that may improve the potency and durability of the top two.
T cell therapies.
We validated our novel approach, which enforces.
Memory phenotype and culture T cells through a previously unexplored pathway.
In an aggressive mouse tumor model and we're building a broad and exclusive intellectual property position around our platform. We believe that our novel approach has the potential to improve response rates for patients receiving either engineered or native T cell therapies for liquid or solid tumors and our.
Continuing to explore the application of this technology to human car T and adoptive T cell therapy systems.
With that I'll turn the call over to Mike Jacobsen, Our Chief Accounting officer for a more detailed discussion of our first quarter financial results.
Rick.
Thanks, Greg.
And as Greg briefly discussed on December 23rd Rainer required Omidria and the associated business operations, the sale required us to restate our financial statements for all periods in two components. One continue operations in the second discontinued operations.
This means that all historical imager revenue and operating expenses are shown in a single line in our income statement as discontinued operations.
All of our other activities are included in continuing operations.
The immediate transaction includes royalties on worldwide sales of <unk> will continue to receive royalties or 50% of net sales of omidria in the U S until the earlier of January 1st 2025, or the payment of the 200 million dollar milestone.
Thereafter, we will receive a 30% royalty on U S. Net sales for the duration of the relevant patent terms, which extends to at least 2033.
We will also receive a 15% royalty on any non U S. Net sales of Omidria over the life of the relevant patents.
From an overall standpoint, considering U S royalties and a reduction in operating expenses, we will receive approximately 70% of the U S. Operating profit when royalties are at 50% and over 40% when the royalty is 30%.
Turning to our actual results our net loss for the first quarter was $33 million or <unk> 53 per share.
This compares to $35 $1 million loss or <unk> 57 per share in the prior year first quarter.
Our noncash expenses for this quarter were $4 $2 million or seven cents per share compared to $4 1 million and <unk> <unk> per share in the prior year quarter.
As of March 31, 2022, we had $142 million of cash and investments available for general operations.
This is a $15 million decrease from the December 31.
We also have $16 million in royalty and trade receivables that we will close this quarter.
In addition, we have an at the market sales agreement that allows us to sell from time to time up to $150 million of our common stock.
Continuing operating costs and expenses for the first quarter were $35 million.
This is a decrease of $10 million from the first quarter last year after reclassifying.
First quarter 2021, Omidria operating expenses of $6 four.
4 million to discontinued operations.
The decrease in.
Continuing operating costs was primarily due to reduced <unk> manufacturing activities.
And reduced in our supplement prelaunch marketing activities.
We continued to gate R&R supplemental sales and marketing spend until the timing of the FDA approval is clear. Additionally.
Additionally, we continue to expense Indian or stop them.
Manufacturing costs until timing of approval in the U S is certain.
Interest expense for the first quarter was $5 million and consistent with the previous year quarter.
Now, let's look at discontinued operations.
As you may recall from our year end earnings call upon the closing of the Rainer transaction.
We recorded a $185 million omidria contract royalty asset.
Which represents the minimum expected net present value of future U S royalty payments.
These minimum expected future royalties are quite conservative as the amount is a net present value computation using a double digit discount rate.
The assessment includes the 24, 5%.
Income tax rate most of which we expect to avoid through the use of our historic.
Net operating losses and tax credits.
And they computed amount is intended to ensure that no downward adjustment whatsoever to the omidria contract royalty asset.
Would be would need to be made in the future.
In the first quarter the actual royalties earned from our bedroom yourselves was $13 8 million.
This amount was recorded as a reduction in the omidria contact royalty asset on our balance sheet.
Additionally, we recorded $7 million of income in discontinued operations in our income statement.
Recognizing for accounting purposes, the interest earned on the imagery of contact royalty asset and re measurement adjustments.
Now, let's take a look at our expected second quarter results.
We expect overall operating costs from continuing operations in the second quarter to increase modestly from those of the first quarter due to the timing of planned research and development activities and the timing of certain employee related costs.
Interest expense for the second quarter should be consistent with the first quarter at approximately $5 million.
Income from discontinued operations should be similar to the $6 million, we recognized in the first quarter.
With that I'll turn the call back over to Gregg Hey, Greg. Thanks.
Thanks, Mike, Let's open the call to questions operator, thank you.
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Press Star one on your telephone.
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Our first question comes from Eric Joseph with Jpmorgan. Your line is open.
Hi, good morning, sorry good.
Good evening, thanks for taking the questions.
I guess just a couple from us the first on the supplement there aren't a lot of resolutions.
Resolutions that we can refer to here so I'm curious.
What the.
Really the Rosiest.
Could be from the dispute process.
Is it an automatic approval will approval cedars decision where to be overturned and.
Wonder, whether there's a middle ground that you might be arguably four perhaps like an accelerated approval.
For conditional approval.
As a compromise.
And then ill.
Second question is a follow up.
Sure well, let me address it and then I'll hand, it off to regulatory as well.
Look what we are requesting is regular approval based on the information the data that are in our existing BLA.
What is the optimal outcome the optimal outcome would be agreement with that which we think is quite clear.
And well supported.
And that would then lead to label discussions and and we're off to the races. Your question about is there some mid ground.
As I mentioned I think in the prepared comments Covington and burling in Heinemann Pulps Mcnamara.
Have a substantial experience in this.
And collectively the outcomes on those that they have worked with or that it is favorable.
For the company.
How that would play out for us, we just need to see.
But you know frankly.
I think that.
When you look at our data which are published.
When you look at what we have said publicly about the regulatory history and I can just assure you that those comments are absolutely accurate if you look at the precedent.
Of this division with similarly, situated drugs in similar indications, meaning life threatening indications and then you look at the literature.
You put all of that together.
We believe.
And I think that that is the royal we and I would extend that to our advisors believe that.
Look we have a very strong case here for whatever reason.
What is coming back as sort of this.
Uninterrupted ability of the results and we just don't see it that way and frankly, either do the experts who do these procedures.
And it was quite disappointing frankly men when we came out of the type a meeting we felt that that had been a constructive meeting in fact are quite constructive meeting we had addressed every one of the concerns that were raised.
Either in the briefing package or in the meeting itself.
And we thought we had made really good headway and that we were being very collaborative about what we.
What we were trying to do not to why the meeting minutes that came back were surprising.
And frankly I think.
Sort of triggered.
A reassessment.
What our next step would be and which path would be the most expeditious and that's how we've come to this we believe we will be successful and we believe that this path provides us.
Success in the shortest amount of time, but let me see if.
Cathy if you would.
Agree disagree with any of my statements or want to add something additional.
Sure. Thanks, Greg.
Really all I have to add is kind of a procedurally speaking in terms of getting a favorable outcome from this formal dispute resolution if the office of new drugs agrees with us that.
Information and the BLA supports approval procedurally speaking, we would have to you then.
Put a submission back into the division and then they would classify that as a class one resubmission because it wouldn't have new data or new analysis in it and so procedurally FTA Dan has two months from our submission.
<unk>.
Reached their final decision and it's during those two months that as Greg mentioned, we'd be talking about final label language and hopefully they won't even take the two months, but again just procedurally speaking that's basically how it works, but again I think Greg did a nice summary of kind of where we where we are in the discussion we had at the.
The poster post action meeting.
Okay, great actually added detail.
Helpful and maybe just a follow up if I could on <unk>.
<unk>.
As it relates to the commercial milestones.
Okay.
Alluded to the no pain.
Act.
Possible pass.
Passenger legislature legislation as a trigger.
I just wonder whether there are any clear.
<unk>.
Route, which you might be able to have secured separate part D payment for that four year period.
As we think about that.
My sense of the review cycle that typically separate payment as well.
Viewed on an annual basis.
Is there any chance to review cycle.
Mike.
Kind of extend beyond.
More than a year.
Sure for multiple years.
Understood.
The answer.
Is that in fact omidria is separate payment under the non opioid exclusion does not come up automatically every year.
Cms's decision on it.
Was.
Was.
A.
Going forward decision, meaning one that does not need to be renewed every year CMS made the decision.
That omidria qualifies under the non opioid exclusion for separate payment full stop.
So you know again, we follow the old PPS rules that come out annually, we look carefully at those but this policy has been in place.
With CMS since 2019.
So we are we expect particularly given the opioid.
Pandemic, that's currently underway.
Net.
This is not something that CMS is going to meaningfully change.
And again the data that are published.
Omidria meets all of the criteria for separate payment.
So it's not an annual renewal.
Okay. Okay. Thanks for all the color.
And thanks for taking my questions.
Thank you. Our next question comes from Greg Harrison with Bank of America. Your line is open.
Good afternoon, thanks for taking our questions.
So after the type a meeting.
What were the critiques that you referenced in your press release and in your remarks that were repeated by the agency.
How could you address those critiques and what about your responses to them did the agency disagree with.
Yeah, Hi, Greg Thanks for the question look.
We arent going to litigate or.
Or discuss the specifics of this publicly I don't think that's going to be helpful to us.
I can say.
That.
There were specific critiques.
That were laid out by the division.
In the Crs.
And we painstakingly.
Addressed ever.
Every single one of those critiques and in a number of cases that wasn't the first time frankly that we had seen or responded to those same critiques.
And I think that they are.
They were.
Our responses were on point.
And that the responses were quite clear.
And so it is surprising to us that some of that came back.
As a refresher.
And I think that.
We we have addressed those.
And we think that those responses that we've provided are abundantly clear.
And this is why I mean, this was not an easy.
Decision for us.
What we were going to do we were surprised by the minutes coming back in.
And we really needed to draft as I said earlier.
The request.
And evaluate that objectively and not only internally, but with our outside experts.
To look at that and to look at our case overall.
And I think given.
The strength of the case and the strength.
Of our responses that documents and other documents that we feel really look it's kind of.
Time to just move on and get this thing.
Fixed and that's what that's what we're trying to do.
Again, let me see if cathay you've got any comments.
Sure. Thanks, Greg.
I think we said before that F D H critiques involved.
Difficulty interpreting treatment response and ask the type a meeting we were able to address these.
As Greg said, we felt it was a constructive meeting in that.
The teleconference is required by FDA, but we felt that we had made good progress toward approval and so again to get the minutes back and.
And not even on time and to feel like.
Some of the same critiques the difficulty interpreting the data we're still there.
Again after reviewing what we pulled together speaking to a lot of experts, including ex FDA people, we feel that this.
This process that FDA has in place specifically for this purpose is the best way to move forward and so that's the route that we're taking.
Got it understood.
Then on the.
The dispute resolution pathway.
Greg you mentioned.
You have a database of examples of companies that have.
Gone through this pathway do you have any information on how many of them are successful the first time around <unk>.
Our goal and.
What gives you the confidence that.
That's right.
Yes, I think in your view.
Likely to happen potentially.
Yes.
And that the FDA was essentially overrule it at that point.
Yeah as.
As I said.
If you look at Covington, and Burling in Heinemann Phelps Mcnamara both groups that we use.
Frankly, both for legal and regulatory advice.
How the collective experience there.
Has been there.
And let me back up a moment and just kind of put this in context correct.
You go to the published statistics, the statistics will say that.
Well less than half of these are successful but success is defined.
As the weather the specific application is granted.
And what ends up happening at least in our understanding with these two firms that.
Do certainly.
A large amount of these relative to other firms is that in the good majority of these cases.
That the outcome is favorable for the company.
So obviously we're betting.
And I think on.
On appropriate data.
And based on on our own BLA that we're going to be successful here. So you know again all of these things have been factored in which is why it took us a bit to get to this decision.
But at some point kind of going back and forth and discussing.
The same specific set of critiques responding to those critiques and then having them come back again.
Every time that takes that takes time right you are going through.
Type a or type b meetings and those take time.
And our position was just look for whatever reason, there's a difficulty interpreting the data.
With within the Division and <unk>.
It is a complex indication and it is a complex complication of a complex.
Disease set right we're talking about.
Stem cell transplantation, and a complication of stem cell transplantation. So.
The complexity is.
As a factorial issue.
But.
We believe that the data are abundantly clear and you know I would frankly love to get in to the details of that.
I don't think that's going to be productive here I can just tell you that.
Our position is that we should carry the day. So we're confident.
Is that a guarantee of course, it's not a guarantee.
But.
Hi.
I and our team are confident in the outcome.
And also in in the approach.
So when you look at that success.
That.
Covington and Heinemann pumps have had I think we're making the right bet.
Got it well thanks again for taking the question.
Thank you and our next question comes from Brandon Folkes with Cantor Fitzgerald. Your line is open.
Hi, Thanks for taking my questions and thank you for the update.
Greg I hear your confidence in.
Prevailing in the dispute resolution process, but can you just maybe help us think through the other scenario if you're doing to prevail could you provide any color in terms of maybe what the FDA is asking for.
What the path forward may be are you committed to an additional trial.
Tremendous pipeline.
Yeah, just taking the other side of the coin, but coincide you say your confidence thank you.
Sure Brendan Thanks, well no look I think that.
Yeah.
Certainly we have considered what the other side of that coin would look like.
But remember that we are the ones that propose to FDA what.
What we would do FDA.
FDA has requested additional information as we have explained previously we believe that we have met not just met but exceeded the threshold.
Four.
Substantial evidence of effectiveness with this drug.
And so our position here is that look we've done it.
And for whatever reason.
Not communicating.
On this point.
So let's go to.
Another group and let's get this effectively adjudicated.
So the result of not being successful on that I think.
Look as I said the majority of these come back with something favorable for the company what would that mean.
I can't speak to that right now.
But again I think that our position is that we will be successful.
We warrant a successful outcome the BLA warrants a successful outcome.
And we are looking forward to getting this process.
Ongoing and then behind Us and having this drug approved I mean again, Kathy Steve any any additional comments.
And then for me thanks.
The data are strong Greg and I agree with you completely.
In my view, there is certainly substantial evidence of effectiveness and compare it to two.
Historical precedent there is certainly strong evidence here.
And I think Steve raises a good point I know I mentioned it earlier, but I just wanted to underscore.
There are substantial precedent not just with an FDA, but within this specific division.
And.
Those those precedents.
Are certainly.
When compared to what we have produced.
We think again put our BLA and a substantially favorable light and I think that again when you look at the data as Steve said when you look at the precedent.
When you look at.
The literature.
And when you look at the regulatory history, you put all that together.
It is just very hard for us to understand frankly, why we were not approved in.
In October of last year.
But how.
How someone looking at this truly objectively.
Could come to some other.
Some other outcome of course that can always happen.
But we've tried very hard to look at this as critically as we can where are the shortcomings.
There can we strengthen.
But I've got to tell you our collective view is this this BLA warranted.
Approval and certainly continues to warrant approval and we expect to be successful.
And I'm showing no further questions at this time I would like to turn the call back to Dr. Dr. Demopoulos for closing remarks.
Well. Thank you again, everyone for joining the call today, we look forward as I said to completing the dispute resolution process quickly and bringing our supplement over the finish line.
In parallel our other programs continue pushing forward.
Near term value driving milestones are coming up throughout 2022.
We will continue to keep you updated on our progress as always.
We appreciate your continued support.
And we hope you all have a good evening take care.
This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.
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