Q3 2020 Ampio Pharmaceuticals Inc Earnings Call
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Thank you and welcome to M. P O pharmaceuticals business update and financial review Webinar. As a reminder, this call is being recorded and all listeners will be and listen only mode. If you would like to ask a question dial star one on your telephone keypad, if youre accessing.
This call by weapon or you can submit your questions online and the ask you a question portion of your screen at this time I would like to turn the call over to Mister Joe has it Joe. Please go ahead.
Thanks wrong and good afternoon everybody.
Yep Yo statements and this Congress call that are not historical fact and that relate to future plans where events are forward looking statements within the meaning of the private Securities Litigation Reform Act 1995.
Oh I'm looking statements can be identified by the use of words, such as believe expect.
Can anticipate and similar expressions.
These forward looking statements include statements regarding a P O as expectation with respect that ambien and its classification as well as those associated with regulatory approvals and all their FDA decisions.
Biological license application the ability of M. P O to enter into partnering arrangements clinical trials and decisions and changes in business conditions and similar events the ability to receive regulatory approval conduct clinical trials, but anthea on maybe used to treat ours induced by COVID-19, all of which are hurting.
The subject of various risks and uncertainties.
The risks and uncertainties involved include those detailed from time to time and they abuse filings with the Securities Exchange Commission, including without limitation on their M. P. O annual report on form 10-K, and other documents filed with the Securities and Exchange Commission.
M. P. I wanted to take no obligation to revise your update. These forward looking statements were the result of new information future events or otherwise with that I would now like to turn the call over to your founder Chairman and C. E O Mr. Mike Macaluso height.
Thank you Joe a good afternoon, everyone and thank you for dialing in joining me today on this conference call or dance Tokely are CFO, then as an experienced pharma M&A M&A person. He has a thousand valuable experience of the ads to what we'll be doing going forward also Laura Goldberg.
She's our vice president quality, she's responsible for the standards, we have in manufacturing in our documentation.
She she will explain be explaining today are positioning on oak with the F. D. A which is fabian because she was responsible for documentation presented to the FDA [noise] also with me today is Dr. David borrower, our founder who also presides over six level, one trauma research centers it.
His his reputation did is that is allowing us to do many of the things you'll be you'll hear about today. So I'll turn it over to Dan it'll be our first speaker and Dennis up to Ya Yeah. Thank you, Mike and good afternoon, everyone and again I'd like to thank you for attending amperes business update and third quarter financial results calling for.
That's cool.
Has Joe previously mentioned that I'll I'll I'll say again before we began the substance of today's call I'd like everyone to please take note of the Safe Harbor paragraph that is included at the end of today's press release.
This paragraph emphasizes a major uncertainties and risks inherent in the forward looking statements. We will make this afternoon. Please.
Please keep these uncertainties address in mind as we discuss our expectations regarding the clinical development process and regulatory approval pathway for ambien.
Potential market opportunities operational outlook and financial guidance during today's call with that said I'd like to go through and a summarized version our our earnings and our financial results for the third quarter of 2020.
Our financial results for the third quarter of 2020.
Are included in our quarterly report on form 10-Q, which was filed with the SEC on Tuesday November 3rd.
And which primarily reflect the ongoing operating expenses associated with our base business and infrastructure support and also incremental costs supporting our ongoing clinical development programs for him.
With that said at first like to touch on the category of research and development costs for the third quarter of 2020 reach.
Research and development costs were $1.7 million.
Which was down 52% from $3.4 million for the same period in 2019.
This decrease is primarily attributable to a decrease in clinical trial in sponsored research costs, which was partially offset by an increase in operations and manufacturing expenses.
To further elaborate clinical trial and sponsored research costs were down one $9 million when compared to the same period of 2019.
As the P O one three or the Oh AK osteoarthritis of the knee study was pause in April 2020, due to stay at home mandates issued by state and federal governments in response to the COVID-19 pandemic and also with respect to travel restrictions, which were implemented by the C. R O.
We expect clinical trial and sponsor three search costs to increase during the fourth quarter of fiscal 2020 in comparison to the current quarter, we just close.
To the continuation of our a P O one four or inhaled and beyond study.
Operations and manufacturing expenses increased 190000 in the current quarter when compared to the same period in 2019 as our manufacturing team produced intravenous and beyond for the a P. O. One six study and in addition during the 2020.
Order.
The FDA granted the company in Indy for inhaled A&P on and the manufacturing team and current costs associated with producing vials of and beyond to be utilized in the AP Oh, one for inhalation and beyond study.
On the general administrative expenses G&A costs decreased.
Modestly by 98000, or 5% five 6% from $1.7 million for the same period in 2019.
The decrease was primarily attributable.
Do a reduction of about 300000 and professional fees, which were primarily legal related fees and that was due to the dismissal of.
Of the derivative in class action cases, and that in the current period. This was partially offset by an increase of about 176000 and non-cash stock compensation expense due to the issuance of stock options to employees and modification of stock options pray.
Obviously awarded to non employee directors.
Net loss, we react denies a net loss for the third quarter of three 4 million compared to a net loss of $7.2 million for the same period in 2019.
That loss reduction of three $8 million was attributable one to the reduction in operating expenses of $1.9 million, which was previously explained as well as a reduction in the war derivative loss of 2.1 million in the 2020 period.
And this was due primarily attributable to warrant exercises and the 2020 period.
Set by the derivative loss associated in the current period due to the increase in the company stock.
From a liquidity standpoint as of September 30th 2020.
We had about nine $4 million of cash and cash equivalents in in April of 2020, we received.
Proceeds of 544000 under the Paycheck protection program for which we have currently filed for forgiveness.
With our lending institution and also received approval from our lending institution for the forgiveness and we are currently waiting approval from the small business administration, which we expect within the 90 day timeframe.
Timeframe.
As as required so we expect to have.
Response, and we expect it to be forgiven in mid 2021.
Q1 2021.
Have to grow through it and emerge stronger the purpose of this call from my perspective is this show you how will do just that Ah Rose R. O. A case study osteoarthritis of the knee study along with many other clinical trial studies conducted by pharmaceutical companies, where paused or interrupted due to the pandemic.
There was confusion as there was no historical precedent for any of US to guide us through this so we all waited for the FDA to tell us exactly what we should do.
That information from FDA did not come right away and for those of US running subjective trials, requiring patient reported outcomes FTA guidance was very important as many as we and many other companies we could just not pick up where we left off.
We finally received guy FTA guidance felt it was reasonable and fair worked on our proposal proposal and submitted our proposal to the FDA.
And we tried as best we could and I think we did a great job of it is following the guidance as to what we had to do exactly and now we'll wait for their comments I will ask Laura who was responsible for preparing the documents to explain the process and what we might expect.
The timing of when they will respond to us is not clear at this time. So as soon as there is a final decision will let you know Laura let you do it.
Thanks. Thanks.
Well you are correct.
So next time and.
Good news is that we do know more now than we knew earlier this year and before I gave everyone on the line and update on our trial at first one I think that the doctor that clinical site and the patients for their dedication to the study and really for bearing with us as we navigate through the COVID-19 pandemic.
And so like everyone mentioned earlier this year, we were in the midst of our largest clinical trial for osteoarthritis of the knee. That's R. 13 study as the country was being hit hard by that Covid pandemic and like Dan mentioned early in the pandemic it was becoming difficult to conduct a trial with our clinic shutting down.
Difficulty is running a clinical trial, while the country was in disarray and frankly, it just wasn't safe to ask people to come into the clinic for their visit because the patient population with osteoarthritis or <unk>.
Individuals who are older and much more likely to have serious health complications if exposed to COVID-19 sales like mentioned before in April we did pause the study and we weren't alone in that I was just recently reading a listing of over 1000 clinical trials that were interrupted by Covid and that article really read like a who's who in the pharmacy.
<unk> industry with companies like Eli Lilly Novartis, Pfizer and many many more also appearing on that list.
And originally everyone probably help the pandemic would be short lived and we would be able to start off where we left off.
But we're now seven months in and all signs indicate that that's really not going to happen any time soon.
So Fortunately there are a couple of things that really do help us navigate the covid situation and provide clarity for the AP 13 trial.
Primarily the FDA has recognize that COVID-19 does impact clinical trial and they released a couple of important guidance documents the.
The first one is focused on conducting trials during the pandemic and the other provides options for statistical analysis of data obtained during the pandemic.
Both of these documents give us insight into what the FDA of thinking and really add clarity when communicating with our colleagues at the FDA.
So using their own guidance, we created a plan for this study in a psych mentioned earlier, we've submitted it to the FDA.
That plan uses a statistical approach as described by the FDA for data already collected in the 83, the AP 13th study to determine the path forward.
Now we are still blinded to the results of the study and the plan aligns with FBA expectations that the information to support our next steps does not on blind us to the results of the trial.
And one thing for everyone remembers that the AP 13 trial was designed to support a commercial marketing application. So as so we are operating the trial under a special protocol assessment or a spa agreement with the FDA.
This means that we were able to submit our plan as an amendment to this path to get agreement on our proposal before moving forward or.
Our primary focus is the approval of ambien as the treatment for osteoarthritis of the knee under a biologics license application. So as we communicate with the FDA on our proposal filing the BLA continues to be our main goal.
Right now I'm going to give it back to Mike and David Bharara will talk about our covid programs, but before I do while I'm talking about the FDA I also wanted to mention that we've been in regular communication with the FDA throughout the development of the Covid program. The FDA has been really responsive and his EBIT reached out with questions.
Late at night or on weekends.
So this is really strengthened our relationship with the FDA and increases the overall awareness and recognition for Anthony on within the agency.
And I'll get it back to make thanks floor.
The entire world has been following the news on the Covid virus all of his hoping for a therapeutically treated and the vaccine to prevent it theirs.
There has been an abundance of misinformation and hype, but few real tangible results drugs had been approved for use with the World Health organization tells us and even the doctors that we know suggest the show little if any benefits.
Every company involved in the testing of the therapeutic solution attached the problem by showing that their drug target sure blocks. It very specific biological pathway that would halt the progress of the disease, but they all seem to be focused on different pathways. Some even seemed to work although temp.
Primarily in for a very short period of time, but not yet have offered a solution to the problem.
So David I want to ask you some questions.
First.
Why is there no consensus as to which biological pathway to address.
The second those therapeutics that show initial promise.
Lose effectiveness overtime why is that.
Why it could empty on be different.
He is the ultra filtrate commercially.
Commercially available in Mds proves human serum panel demand.
We manufacture MQM in house.
GMP facility.
By proprietary process.
We removed the albumin for the commercial solution and used to very low molecular weight fraction.
That remains after removing cost remained.
As such came John.
He then Inc. was solution that contains several low molecular weight compounds.
Which have biological activity.
Pantheon could be regarded as a biological cocktail of drugs.
Or.
Four intimately involved in the COVID-19 pathophysiology.
We have identified these effects of Antioch in various sale lines that are important in inflammation such as endothelial sales.
Which line inside of blood vessels by demonstrating beneficial effect on vascular permeability, so that immune sales and fluid to not leak.
Into tissue like in the long and hold the brain.
We also reported and published on macrophages, we demonstrated the transformation of the 10, one throw inflammatory macrophage into the aim to phenotyping genotype macrophage involving wound healing and anti inflammation by hand count.
We also found that the healing pathways are activated by NPR.
Initial.
Inflammatory response to a pathogen who injury is a good thing.
It is there to eliminate insult to the option of both the Nathan and adapted immune systems, but it has to be controlled by older biological systems designed to do so.
It left and control of this regulated as observed in the decisive can store and some of the COVID-19 patients severe.
Severe sales inflicted damage occurs.
Result in severe clinical manifestation and even that.
Such one control system is approached against the gland in pathway.
Prostaglandin small specialized fast that regulate inflammation among other effects they have we.
We found at Antioch regularly.
Beneficial prostaglandins that are anti inflammatory in contrast to the effects of steroids do have anti inflammatory properties, but also abolished inhaling effect mediated by this post atlantans.
And.
All of Us know.
Terry have major side effects short and long term.
And we just have recently discovered the NTR.
Also upregulation important protein involved in preventing blood clots.
Protein is strong both modules.
Trauma module leanings of protein on the surface of Angelus kilo sales.
And the receptor of the probe closing protean tromping.
By Trumping binding to travel module mean, an enzyme protein is activated and prevent dispositional small filing cloths and blood vessels.
Trouble Trumbo moderately and also affect fuel Trinity compliment system.
The accelerating the degradation of six three b, a major component of the compliment system.
The compliment system has been described are very important and does this regulated immune response and COVID-19 patients and has been the target of many compounds biopharmaceutical companies to diminish that this regulated immune response seen in covid patients.
We beneficially affect the system the compliment system, we Danielle.
To the multitude biochemical tax base I described inflammation.
Esculent permeability confident in system, what relation blood clot formation and healing factories.
We have an entry in a cocktail of drugs that attacks the problem in a multi targeted approach.
Is this approach important.
Because in robust biological pathways boring for a to point b.
There are usually multiple routes to each point b.
Looking one road may have been initially said, but very rapidly alternate pathways erodes.
Going to bypass of luggage and the initial effect face.
Statutes accused for drugs.
Angle target oriented drive blood testing P&L klotzbach.
Six any specific compliment system components et cetera.
To be successful you have to have a multi targeted approach it is analogous to cancer therapy.
The usual treatment and cancer utilized utilize a cocktail of drugs and also radiation as opposed to using one specific drive only.
Such as the kids with banjo as I discussed multi targeted approach.
Why is it why is empty on clinical program what is the Henckel clinical program for COVID-19.
Two days.
We have been granted July nd for the treatment of COVID-19, Antiar. The first indication on multiple delivery is for the intravenous administration of pantheon, two hospitalized moderate to severe COVID-19 patients needing oxygen supplementation wait.
<unk> bye, Matt or by Americans mechanical ventilation.
This study was conducted the General Hospital Barton Springs, Colorado to try included 10 patients.
By a nebulizer four times per day.
D.
Prior to this clinical trial.
Fancy valuable studies of manipulate zone IMT on where perform.
And reveal no adverse events or talk to that effect.
Any of your animal organs.
The inhaled ancient plentiful dryer.
Was already initiated a finger results will intervene expanding to other U S hospitals.
We also have been approached by internationally universities and hospitals to participate in his clinical trials or modified ones.
Collaborating to research with them.
I also am digit.
As possible combination of fancy on with an empty violence rock for example account business combination we re-met severe orders.
Pre-med severe has been shown to be.
Not effective in reducing mortality and more vast morbidity year. It was recently approved by the FDA.
Severe effects viral replication bye.
25% of people interviewed indicated that they will take the vaccine when available.
With a vaccine protect from viral mutations that are already being reported.
Will do vaccine have long term side effects.
Many unanswered questions.
Except I want you to think about this.
We went from doing giving a patient far mills every 12 weeks in the knee.
To 250 miles into the vascular system every day.
His inflammatory conditions can be effective tool in treating kinda in these conditions, David I have a couple more questions for you.
Dr team here and Chew on hospital team.
Blue.
What the pathway too inflammatory frankly is.
To have an peon given to those patients to prevent pov and perhaps even the heart transplant.
Currently it treated with steroids.
And do it may be issued some effect by then.
Rapidly so postponing npov is once condition.
We are exploring.
The other one.
Is oh, one where it was discussing with the prominent professor of cardio.
Paediatric cardiac cardiology.
It's a process of currency.
He syndrome.
We still have O K I feel very good the OA K as in a very good place may be better than it's ever been.
So what we're trying to do during this period, while we are waiting for the FDA is to build our portfolio and create more value the fourth question.
You started with an Ivy trial it work you're not running a second Ivy trial now lets you move immediately to an in inhalation study why.
And that Dr. Bauer explained this but I want to do it a little bit more in detail. We started with an infill inhalation study with the FDA to address the breathing issues associated with colder.
To do that inhalation study the FDA required us to do bench experiments, which we did in past particle size and flow studies on both ventilators in Naturalizer is which we did and at the last minute and animal study.
Okay. So.
First of all.
The baseline.
Sickness of the patient, but the severity of their condition was equal with no one group seeker than the other and that was is determined by the cardinal's scale Dardanelles Chili's, a categorical scale that was developed by the World Health organization. So doing the same beginning stage.
Second I'll do five patients died so we are in the control group for received remit to beer and in the Amnion group numbers that.
That was not by design that was.
By chance.
Spiral the best COVID-19 treatment strategy.
Yes, I think so.
Touched on it when they call.
For example that gives the example of using the net severe and Antioch.
<unk>.
An empty viral.
Decreased via low and again as I said, we need to use it fairly early on because after that even if you would use a viral load you don't have any effect on.
The consequences of the universe on.
So initially evening, a drive rhonette severe or other antiviral drug.
To reduce the viola and is followed all at the same time, given and beyond to prevent the latter.
Inflammatory response this regulated is what's killing the patients so a combination certainly do.
The way to treat patients small.
Thank you David.
Can we open up the lines for costly.
If you would like to ask a question. Please press the star and one on your Touchtone phone.
And you may remove yourself from the queue at any time I pressing the pound key again to ask a question today, Please press star and one.
And we will take a question from Jeff Laskey. Please go ahead.
Yeah, Mike what does the company have to do.
How many different.
Diseases or symptoms does the company have to show Amp beyond works on before Big Pharma considers amping up on a platform technology and second question, how long will it take to do this.
This answer your second question is we're doing it now and how long it'll take I think with some clarity from the FDA on oak.
And a continuation of of what we're doing now.
I would expect some of these things to happen as soon as they can I mean, we're waiting on OPE. That's the furthest along we are on any one development program and we're very far along on that hopefully we're at the end and and the things. We're doing now will just add value to that so just I think we're doing we need to do and we're doing it as quickly as possible.
Okay, My operator, yes, Sir.
Again, if you would like to ask a question today, Please press star and one.
We will take a question from Peter Coley.
Hello, I'd like to ask if you could briefly explain a little bit more on the ATM process.
I know you mentioned, it's a disciplined process.
I appreciate just wanted to know a little bit more on.
How that kind of works and how it affects the stock price.
Well, we try and manage it so it doesn't affect the stock price one of the one of the difficulties in raising money is that.
For whatever reason the prices always seem to go way down while you're in the course of raising money. The ATM is at the market. So we try not to affect the price at all we could control. It we only to tell you we only need to take exactly what we need. So it's just a much more manageable manageable process and and Dan Kid.
Add to this if you'd like to but as I mentioned to me there's no good way to raise money. When you are pre revenue right. It's all dilutive.
So this for US this is the least dilutive the most control way. Our goal is obviously to get to a point, where we're getting non dilutive cash right. That's the the most beneficial way to raise money everything other than that is dilutive. So we view I view, the ATM as the better bad choice.
So the best Bad choice, Daniel one AD elaborate a little bit and our goal since I've come on here.
And since we have to actually put the ATM back and.
Late February early March.
Is.
Attempt to keep.
As much as possible about eight to 10 months of cash on hand on a forward looking basis at least how we say expenses today with what we know today on commitments.
On a disciplined basis will remain by that is.
To turn it on an overall basis the ATM.
Right at about 10% of the total trading volume.
Not a perfect number but over the course of the nine months roughly that we've added up or a total percentage of shares traded is about 8%.
And our dilution is south of 13% on a fully diluted star.
Sure of outstanding measurement so.
That's our current process and.
As we get.
Positive news, that's more substantive data.
And there is cleared trajectory of value, we will certainly go out and seek.
Additional financing is needed through more traditional private or public offerings.
Next question operator please.
Our next question comes from David break him. Please go ahead.
Mike.
I think I'm understanding are you're hurting me all right.
Was which was substantial.
The biggest block of KL four patient history that exists and all that data when combined against the sales and control was statistically significant.
I believe and I'll tell you I'll answer the question in the same way I've been answering it to big pharma.
I believe that our historical data and if the FDA accepts the guidance, we they provided us if they accept that guidance.
And we followed it is carefully as we think we did then when we unblind that data it should be very similar to his our historic data and the two combined should give us the opportunity to be able to file to be la. So I think we're further along or as far along as we could be and I think our sales.
Data combined with this assuming our dad is.
The way it's always been.
I think will put us in very good shape. So.
Thats, where we stand.
Thanks before you all year ago, you said that.
You had some partners are and the way things slip as soon as we got approval.
They'd be.
You'd be able to get some sort of.
A build on the go.
Go downtown with this thing.
Okay. So we have been we have been in touch with those companies are still following our progress.
There are waiting is carry as much as we are to see how things turned out with the food and drug administration.
I don't believe personally I do not believe that there's bad news that could come from this.
I do not believe the FDA send everybody guidance to say go ahead and start all over I don't think Thats why they did that I think they gave us an opportunity to take advantage of what we've done and to be able to combine it and take a look at it and allow us all to move forward. So thats, what I believe will happen. So I think we're.
In really good shape I'm always optimistic about how good our dad is going to be and I think we'll.
If the FDA accepts our proposal, we'll go ahead and Unblind it and if it is good as I think it will be then we should be able to go ahead and file our BLE and I don't think we need to get approved to get to get our.
To get things moving along I think once we have that clarity from the FDA will be able to consummate some of those discussions.
Next question operator please.
Again, if you would like to ask a question. Please press star and one on your Touchtone phone.
We will take another question from that Peter Coli. Please go ahead. Your line is open.
Can we count on you you said you are going to improve our PR.
I love the new website, I know, it's not associated with with and be it you know the actual company itself its a investor related.
But can you said were going to count on you for increased PR.
Is that going to start possibly with the safety Committee meeting with you on the first three patients had.
Had the nebulizer.
If you're going to find out if we're going to continue this trial you know with the next group of patients can we count on you for a PR the minute you find that out.
We could count on that we've hired a PR firm that we're gonna take guidance from the PR firm on what we need to do not just the PR firm understands why they've been hired and what our expectations are we understand that putting out press releases and just go were going from press release. The press release is not enough, we get it and when it.
We will take a question from.
Rich Lurch Min. Please go ahead thank.
Thank you Hey, Mike.
Alright, well, Hey, Hey, Matt following up on the last question is the significance of the FDA agreeing to use historical data does that basically mean that rather than having to complete the trial, which was interrupted.
We finished about 500 and some patients as opposed to the thousand that the that the S.P.A. called for can you use the historical data.
On.
An additional 500 patients to basically negate the requirement to do the other 500.
Is that how it works is that why you won't have to do anymore.
Testing on any patients because you can use old data and supplement it with the data that you're going to Unblind is that is that how it fits together.
Oh I'm going to let Laura help me with this I'll start out and then Laura you could jump in if you like.
I think this rich and you know I I know, how the FDA exactly things I don't really know or understand but I believe that because our historical data is strong they wouldn't have given us an S.P.A. on a final pivotal trial, if they win that wasn't supported right.
So when we if if they accept the proposal we sent them, which is based on their guidance. It wasn't a proposal. We just made up or decided I think we'll do it like this they told us what we needed to do and we did it.
When we Unblind that study indicated when we unblind.
Pardon me, what your what you needed to do to do what to accomplish what.
To accomplish so that we can use that trial as the final pivotal trial right.
So that's what it was designed to do that without any more studies without any more clinical studies well I'll. Let me let me explain what just to give me. Another second then you could ask ask me again, if I didn't answer it okay. If we take if we take that data.
And that data mirrors, our historical data in other words, if the data looks like it always did we got the biggest block sales khail for historical data that exists.
It's combined and statistically significant against sailing yes.
We're showing that same kind of presence and this and this data when it's unblinded it'd be great. If it statistically significant but if we're showing the same sort of affects event beyond hopefully that will be enough flooring, you want to add to it yeah. I mean, I think I would add that the plan that we proposed to the ft and like Mike said.
You know what recognized in their guidance is a valid approach you know for addressing the impact you know that cobot had across all clinical trials and it really balances the statistical power of your sample size as part of the the methodology. So the numbers you know will fall out with.
The conversation or the communications that we have with the FCC and how the spinal not.
That is the intention of the amendment it too.
Well, you know kind of gas.
Guaranteed or gather agreement for a biologics license application and to look at the the population that trial in order to do that.
Laura that would still as you described it that would mean no more clinical trials wouldn't have to test one more knee patient with amp yeah.
If they agree to that yes, yes, okay and the guidance that you're both referring to is that guidance that came out as a consequence of the of the them stopping the trial because the cobot and then they said, okay. Here's guidance as to how we can move forward is that what that guidance was.
Yeah. So rich it's even it's more complicated I was talking to farmer. During this whole process. So what pharma being really really big pharma and mid sized pharma midsize pharma is really big too.
And I asked them some of them had 15 files 20 trials there were interrupted during the cold period and I ask those people what they were going to do it.
And they had no idea just like we did they were waiting for guidance from the FDA just like we did.
So companies that perhaps we're running trials that were more objective then subjective like for example testing blood if they were able to gather those test then maybe they could still be valid, but if they couldn't then they're totally invalid right. So there is no way so what the F.D. basically said to us is law.
As I mentioned, you tell us give us a proposal based on these parameters.
And then will Unblind the trial and if that data looks promising if its statistical. So it was 500 patients for us whatever the number what is.
Some of our trials were statistically significant with 100 or 329 patients.
So if your data is the trials working in and ours usually have.
And that tail for group.
We should be in good shape here is this is the Afghans lines I think the comment Laura made at the very end of her presentation is very important to consider.
You know relationships in advocates at the agency are very important I think by doing the extreme things that the FDA made us doing the testing the ventilators. The the Nebulizers. The animal study that spend science, we had to do.
Submitting 500 page documents working weekends to answer questions. It should it take in 30 days, we did over the weekend receiving calls from the FDIC late at night on a Friday early Saturday morning. So late at night to US is eight nine not that's 11 or 12 o'clock at night on the East Coast.
So those kind of communications those interactions our ability to successfully achieve what they were asking us to do on short notice with a very high standard right very high standard.
To to have acceptability, we accomplish that hopefully we've improved our relationship with the FDA for the first time ever in my opinion, the FDA I actually read through our peer review journals looked at our science and do I say that because I was hopeful no because I can tell by the questions They were asking us.
That they had actually reviewed and looked at that 500 page document that the actually read some of the peer review journals that never happened before.
Also we were never asked.
To to do an animal study before.
Why would they ask us to do that because we would all say on the phone probably 500. However, many people on the phone and beyond is very safe, but when they moved us from where we are are where we've always pen to all cat, which is tissue, which we've never been in nor should be.
They had a different idea, whether we were safe or not so being able to run these safety studies being able to run the studies on the equipment seeing the results of the things we're doing with these covered patients.
Seeing the proposal we send to them on Oh, 8-K should all help us I mean I'm optimistic about it we'll see what happens so.
Yes, okay.
Oh, there you go I mean, that's the best news [laughter] there could have been delivered to the shareholders of this company in a long long long time, you're right on the threshold of.
Making something meaningful happen.
I would say I would say rates were at the very beginning of the EPS is how I would describe it we're very close but you don't need you won't need.
Any positivity from the inhaled.
Study in order to continue those discussions would you know.
Here's here's just saying here's the thing, though that's critical and I want everybody to understand this you know we could say all day, we're a platform technology and we are.
But now we're proving it.
Very shortly we'll have results on the inhalation study very shortly.
We'll have we'll have reports on how we're doing on the inflammatory untreatable kidney diseases.
We'll have information on possibly on rare children's diseases. These are called mid related right. This is all just about coal being right right now when you're talking about a company. So when you're talking to big pharma and you say, Okay. You guys interested to know AK and they say yeah well.
And Weve had serious discussion.
So now we're waiting but are now you add to that.
A drug that can be used not just in the knee, but in the other joints and you now we're talking about 250 and metals in the vascular system for systemic inflammation.
30 to 32 MLS right into the lung and does that thing that David glad glanced over.
My daughter plays college volleyball for players on her team tested positive for Cove. It one was hospitalized one got really sick to add minor symptoms three of those four players.
Have abnormal heart conditions right now.
There is nothing to treat that.
Right. So we believe that Theres, we would be able to offer some solutions to that.
And Thats why all these little trials were doing in the way we're doing them in the hospitals were doing a Matt.
Add credibility to our story.
Got it well then maybe maybe the.
The oak resolution as a program upon which you begin discussions and maybe they get amplified by all these other trials and you make the case that as a platform technology and that that both the deal and I don't know, what but getting done and letting the discussions begin in earnest to me.
It's a huge huge huge step something we've never come close to before.
Well, we were there right, which were there so as Fabulous I hear you I agree okay, well, thanks, a bunch, Mike and thanks, David Thanks, Laura.
Thank you.
One last question operator.
We do not have you run in April.
We didn't K will then further questions okay.
Okay, well. Thank you guys for listening I hope you have learned a little bit more you can hold me to my word that were going to be a lot more aggressive and assertive in in our information coming to the public.
Uh huh.
And we look forward to finishing what we started and I promise I'll keep you appraised so.
Stay healthy stay safe and good luck to us. Thank you good evening.
This concludes our program.
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