Q4 2019 Earnings Call
Good afternoon, and welcome to the Eaton's Pharmaceuticals fourth quarter 2019 financial and operating results conference call. At this time, all participants are in listen only mode.
Following the formal remarks, we will open the call up for your questions. Please be advised that this call is being recorded at the company's request.
At this time I like to turn it over to David <unk>, Vice President of business development at Eton Pharmaceuticals. Please proceed.
Thank you operator, good afternoon, everyone and welcome to Eaton's fourth quarter 2019 Conference call. This afternoon, we issued a press release that outlines the topics we plan to discuss on todays call. The releases available on our website eating pharma dotcom joining me on our call today, our Shawn Johnson, our CEO and Wilson Troutman our CFO.
Before we begin I'd like to remind everyone that statements made during this call may contain forward looking statements and involve risks and uncertainties and could cause actual results to differ materially from those contained in these forward looking statements. Please see the forward looking statements. This cleaner disclaimer in our earnings release and the risk factors in the company's filings with the FCC.
Now I'll turn the call over to our CEO Sean Brynjolfsson.
Thank you David and thank you everyone for joining us today.
Well the fourth quarter was an extremely important quarter the comps for the company and today I'm excited to share with you an update on by orphan as well as some of our other important milestones achieved with our pipeline products.
With that our CFO Wilson Trotman will then discuss our financial performance I will close with the Q when they sell sure.
So starting off with by orphan as most of you know why orphan was approved in the fourth quarter was commercially launched in December. This was a critical milestone for company and I'm very proud of the team's hard work to achieve our first product launch and drills, two and a half years.
Your assumption.
As the first and only ready to use formulation of Injectables on the waterfront why orphan for fills a critical unmet need within hospitals before its approval hospitals had to manually dilute concentrated formula in order to use and or views of this was both time consuming and also introduced risk due to potential calculation.
Dilution errors in.
In order to offset this risk some hospitals were purchase on approved federal law friend from compounding facilities. However in reality this amounted to just a transfer risk rather than a true risk reduction in most cases.
With the introduction of by orphan, we have now provided a cost savings to hospitals longer shelf life and most importantly enough did approve product for patients.
In January we announced a partnership with accelerator for the Copromotion a by orphan.
So he is existing yours hospital base Salesforce will promote by worked into certain customer segments.
This approach has several advantages for Eaton first it will save us a significant amount of money and asked you know and more importantly, it should lead to faster adoption of by orphan due to accelerate as existing relationships with hospitals that have adopted ready to use products in the past.
Accelerate with Salesforce was previously focused on the promotional bank already are ready to use formulation of vancomycin injection, which has the same call points and the similar value proposition to buy orphan.
Interactions with target customers have increased significantly since we brought to accelerate onboard and we strongly believe that the co promote will be a win win for both companies.
Initial interest and by orphan has been strong and we have had already we've already had over 100 different institutions, placing orders for four by orphan since launch.
The onboarding process for each hospital is unique some hospitals and surgery centers converted to buy orphaned within a week.
Well some others typically the larger institutions require buying for multiple departments and committees before converting Oh. This could lead to a two to four months or let's say delay or cannot conversion timeline the larger the hospital or the longer process as you can imagine.
We are starting to see pulled through benefit from accelerators expanded reach and we expect to see an even more pronounced benefit in the second and third quarter of this year.
Pharmacy directors at our target hospitals have specific we've been excited about the following.
Aspects of my orphan.
First by often as a three year shelf life. This is unusual in the pharmaceutical industry. It also allows them to Soc, the product and reduce the risk of Pravin shortage.
The lack of manual dilution and calculations this reduces risk of medication error and says physicians critical time and using the product.
And thirdly, the products up did approve status during the quarter. Many of our customers continue to experience supply disruptions with unapproved federal upfront that they had previously been purchasing from compounding facilities, some of which are known as Bible three be facilities.
As many of you probably saw Amerisourcebergen announced in January they were completely shutting down the for medium compounding business. This is one of the largest or was one of the largest compounds in the United States for medium had previously been one of the leading compounders not just in this product, but in other products supply disruption was significant.
We believe that based on it is regulations compounds are no longer allowed to sell components on a lot for now that by orphan has been approved.
Our legal counsel sense, such notifications to compounding facilities and we are engaged with communication with the FDA regarding enforcement of their own regulations against these compounders.
But to have an in person meeting with the uptick in April to continue this discussion.
On the GPL front.
Group purchasing organizations, we continue to make good progress and I'm pleased to announce that on February 1st we secured our first TPL contract with Premier which serves over 3500 institutions. We remain in discussions with other GPRS and expect to secure additional contracts in the coming months.
Regarding market size, we continue to believe the federal upfront addressable market is more than 20 million units a year by orphan.
Our goal is to capture lose 4 million units long term and potentially many more up to your regulations are enforced and lead to compounders exiting the market.
We remain confident that our manufacturing partner has ample manufacturing capacity to supply the market for the ready to use funnel upfront.
Well, we had been pleased with the strong initial demand for by orphan at an ample after conversations with multiple customers. We believe we also have an opportunity to convert more of the market at a premium price point with the introduction of both the vial and a prefilled syringe container system. We've initiated that work on these line extensions which weeks.
Back to file a supplements to our existing Andy yet and they could potentially large launch in the next 12 months.
In addition to buy orphan we've continued to made great progress advancing our late stage pipeline candidates a few of the net major developments include in December were submitting an anda for DS 300, We believe we are the first to file Andy a on this product. This entire this when entitle us to 180 days of generic exclusivity upon sale.
Access really challenging the innovators pad.
We also estimate that the current market for deals 300 as more than 60 million annually. So we remain very excited about this opportunity.
Also in December our partner Barcelo submitted to the FDA and amendment for the Am 100 product. We believe this amendment completely addresses all the issues raised by the FDA and we expect the product to be approved on a target action date in August of this year.
On our 81, all five of the Motor June product as we previously discussed in February nine two FDA has requested that we made minor changes to the dosing of the administration's sections of the product label and run a human factor study to confirm care got caregivers can follow the revised instructions.
We will be unable to complete the study by the current March 17, PDUFA date, So we expect to receive a CRL.
We are submitting of study protocol to the update in the coming weeks and we anticipate completing the study in resubmitting to the FDA during the second or third quarter. This year, which still allows for potential approval in the fourth quarter of this year.
I'm happy with the progress we've made this quarter and for the full year 2019, advancing our pipeline.
With the addition of the DS 300 filing in the fourth quarter. We now have three products under review with the FDA an additional five products that we expect to file Andy's for later this year I continue to believe we have one of the strongest five will probably be two pipelines and industry and we expect this pipeline products to provide sustainable growth for many years to come.
Lastly, and perhaps most importantly, I would like to say that we are actively continually pursuing high value business development opportunities. We are on the hunt for late stage development projects that fit strategically into our portfolio that could provide near term revenue.
Well, it's impossible to predict the timing of future deals we are optimistic about our ability to close value, creating credit transactions. During this year with that I would like to turn it over to our CFO Wilson treatment.
Thank you Shannon revenue for the fourth quarter of 2019 was 0.5 million from by orphan stocking orders placed by wholesalers during the quarter.
Our full year 2019 revenue was 1.0 million and consisted of 0.5 million milestone payment received from Bosch health to the acquisition of mm 100 marketing rights as well as initial by orphan sales.
Cost of sales for the fourth quarter of 2019 and also the full year 2019 was 0.5 million, which consisted primarily of that profit share cost due to edens licensing partner for by orphan.
Under terms to the licensing agreement our apart our partner was entitled to achieve the first 0.5 million of profit from commercialization of by orphan.
There was no cost of sales associated with the 0.5 million milestone payment received from boss shelf for mm 100.
Recent Shouldnt development expenses for the fourth quarter of 2019 totaled 0.2 million compared to 1.1 million for the fourth quarter of 2018.
R&D expenses in the fourth quarter of 2019 reduced by 1.8 million due from due to Eaton.
Receiving a refund credit of its original licensing payment for 82 or three.
The 1.0 million licensing payment had originally been expense in the first quarter of 2019.
The refund from synthetic was recorded as a component of prepaid and other current assets at yearend and was utilized in the first quarter of 2020.
For the full year 2019, R&D expenses were 11.6 million compared to 5.6 million for the full year 2018.
The increase was primarily driven by 4.0 million of total expenses for initial licensing payments for by orphan and also 81.5 as well as increased head count in operations costs associated with the company's research and development lab that which opened in late 2018.
Selling general and administrative expenses for the fourth quarter of 2019 were 2.4 million compared to 1.2 million in the fourth quarter 2018.
The increase was primarily due to increased sales marketing and distribution costs associated with the commercialization of by orphan higher employee related costs from increased headcount and higher expenses associated with being a public company.
For the full year 2019, or SGN expenses were 7.6 million compared to 4.7 million for the full year 2018.
The increase was primarily due to higher employee related costs from increased headcount increase expenses associated with being a public company and for the commercialization of by orphan.
The net loss for the fourth quarter of 2019 was 2.7 million compared to 2.3 million net loss in the fourth quarter of 2018.
The increase was driven by higher as DNA expenses, partially offset by reduced R&D expenses.
For the full year 2019, our net loss was 18.3 million compared to 12.7 million for the full year 2018.
This increased loss was driven by higher SGN, eight and R&D expenses in 2019.
As of December 30, Onest, 2019 reported cash and cash equivalents of 12.1 million in.
In addition, we utilize the 1.0 million refund credit from synthetic.
Which is reflected component in prepaid and other assets at December 30, Onest 2019 in the first quarter of 2020.
With that we would now like to open up the call for your questions operator.
Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key.
Please standby, while we compile the Q1 a roster.
And our first question comes from the line of Andrew Dsilva with B. Riley.
Hey, good afternoon. Thanks for taking my questions. So just right out of the gate.
That approval that you obtained.
Did you have to also pay.
An approval milestone during the quarter and was that recognized in R&D, It's just I'm trying to.
Extrapolate what a normal right normalized run rate should look like.
Yes, there was a $750000 payment, but that was capitalized because of is tied to the approval of the product. So that's on the balance sheet and being amortized over a five year period.
Okay, great great and.
Going forward as as we think about some of these.
Co promotion and co marketing partnerships with.
Additional products once they're approved.
Should should we expect that is maybe a strategic shift from an opex standpoint and to look for.
Maybe additional sales teams for different verticals to be a little bit smaller than we previously expected as you look to utilize that as a marketing tool.
This is shown in Brazil.
So we're very excited about doing the deal with access to offer or some of the reasons mentioned in our press release.
Regarding the what we'll do as we get additional product launches that will be determined on a case by case basis in some instances we will.
Launch the product, especially if we have another hospital, probably we started bill hospital business.
Who knows what was that our but this made.
Yes, the most on some by orphan for a couple of reasons, we still keep a channel for ourselves it's still marketed under the Eaton name and we're doing the contracting of the benefit accelerate.
Thanks to the table is really the customer penetration the uptake of the product.
There were out in the field they've got another product where they can add this is linked to the back now with regards to some of our upcoming launches now we'll look at opportunities, perhaps something that would be reversed where we have the sales team and we bring another products that other companies have approved for don't want to launch their own sales team. This is a model.
I think will become more and more popular with smaller companies, where it doesn't necessarily make sense to have a sales team devoted to one product and that two smaller companies with products can work together.
Achieve.
On an objective that benefits both sides.
No that makes a lot of sense and then as it results to E. M 100, I take it at the Amendment that was filed ended up not being a minor amendment just based on the timeline there and it was originally I think we're thinking about three months.
That is correct. They did not want to cloud reclassify as a minor amendment they'd love to it as a major 'em. We did not feel it was a major amendment, but who started with the FDA.
We do believe the response is complete.
And I believe bausch long as indicated second half launching the product so.
You know what they asked us for we gave them exactly what they asked us for.
Okay. Okay and this is just more of a question over the next couple of years, you, obviously have a very robust pipeline.
But you can looking back over the last call. It 12 18 months, you had couple of products slept well get CRL as or timing fell off.
You take maybe you are running a little bit to lean on on the clinical side and it might make sense to to bring in additional help as it relates to managing set the pipelines for that.
As we can stay a little bit closer to the original timing from from sure. It's a fair question I think I'll answer that.
As a way Thats. This reflects the reality of the situation we've licensed products.
No two of those of the CRL with regards to.
One of our products was a partner subsea oral and the share role with Lamar Trojan was also the partner there handling the regulatory.
Were there to support but that and that case, we could have done anything differently.
In terms of zero SCO with Lamar Trudging.
That was.
It was quite provides clarity to us on.
Started that's relatively straight forward to do Thats why we still believe we'll have a launch or say approval later this year and.
In terms of avoiding CR roles in the future Ken I can never say that would you know that's the question, but it is something that we balance against the opportunity so file.
Way to avoid all CR roles as to only license products that are perfect and have perfect files.
In that case, we wouldn't miss out on a lot of.
Opportunities that we for all our value enhancing to the company when you're talking in the Grand scheme of things over delay of months.
This is not a standard CRL that a big pharma would get large pharmaceutical company gets the CRL and their stock its crush because their clinical trial failed or the goes after they've been like their clinical results. Other types of cereals, we're getting or more like a deficiency than anything else and it's really up you know we want ex wife I.
And to what you've done so they're not show stopper CR roles. Unlike CFO roles.
I don't want to name names, but the larger companies would actually got it.
Okay. Thank you very much and best of luck on for this year.
Thank you.
Thank you.
Question comes from the line of Ram Selvaraju with H.C. Wainwright.
Thanks, very much for taking my questions can you hear me.
Yes accounts.
Hi, Thanks, So first and foremost I wanted to.
Drill down a little bit on the prospects going forward for by orphan based on the potential for aggressive enforcement action against compounding.
Folks.
In the Central African market so.
I was wondering if you could maybe give us some additional context here regarding you know precedent in cases, where the FDA has been aggressive on enforcement.
With respect to compounding of all their products that might be considered analogous to the situation.
And then secondly, if you could maybe give us.
Some scenario analysis, what happens if the FDA isn't as aggressive as you might hope they would be in cracking down on compounding of phenylephrine.
Sure. So always several it's really three points in your question.
First part is what are we doing I can assure you were actively engaged on the on the topic of this as a rule that the FDA has which is called the essential coffee rule, which prohibits compounders from making a central copies of products, which are already approved.
So by orphan clearly is a product that would fall into that category, where we have an approved product and compounders are making.
Yeah.
Okay. So I don't want to call them generics, because they're not even approved but making duplicate formulations, which do not have the safety and efficacy of review by the agency and so there is no assurance of safety or efficacy. So it really poses a risk to the public.
We have communicated to those compounders that are.
Our providing.
Ready to use versions of federal law firm and.
By and large all of them want to continue doing that and so really requires an action by the agency to prevent up.
So we are in dialogues with the agency to make that happen.
I'll leave it at that but it's active ongoing and we expect action in the future.
Secondly, examples of probably the most recent as vasopressin that was a product received approval. There was a lawsuit between endo and Sagent and a one that lawsuit and I think the FDA was also.
Involved in that were of the agency supported and those position.
So that product was ultimately the chapada product was removed from the market. So now today, if somebody wants to compound.
As a pressing you have to buy it from the innovator.
Thirdly with regards to the agency exercising enforcement agency has exercised enforcement on on grandfather products, which are also not approved not reviewed for safety and efficacy. These are products, which are out in the market, but when someone receives approval they normally of it.
Year to get off the market and agency has exercised in force enforcement in the vast majority of those cases to remove the unauthorized product from the market.
This is no different where you effects worse, because it's not being made under GMP conditions.
In terms of a traditional FDIC GMP site that that makes finished dosage products, which get approved.
These products are compounded products and so we believe the agency will exercise enforcement against Compounders with regards to approve products, which are already approved I.
I think this is a this is the type of case that they'd want us to win if we were not successful it would open up a pandora's box of companies, just going and compounding and picking the products. They want and then launching them there'd be no reason for any of FDA review or any type of approval process for any product.
It's probably more I could say on that but for the second time I'll kind of stop there.
Okay. That's very helpful context, thank you.
Just wanted to clarify also with respect to eat T 105, the re filing would that be what do you expect that to be formally classify that class one or class to be submission.
We expect that to be a club to resubmission because it we believe it pertains to safety.
Safety is a large bucket, but we believe that the agency has requested us to update labeling for example, and to run a user study user study one is there to demonstrate the patients can safely administered the product. So we believe that falls under safety plus the this.
It is really small this isn't something that would take more than a relatively or you know a day or two to take a look at the report did it past validation requirements or didn't to this isn't an exhaustive review. So we believe this would be class too.
But even if it was im sorry, plus one it even if it was class two we still would expect approval towards the end of the year. So you're looking at a two month time versus a six month time.
And you are going to announce when do you refile correct.
Yes, we will.
Okay. Just a couple other very quick ones here can you just.
Remind us what the background was to be E T two or three CRL.
The reason behind that why that happened and then.
Also can you just clarify whether all of your.
Licensing arrangements like that are like the one with synthetic have this.
Clauses in them, whereby if the product gets the CRL you get your original licensing feedback this just to clarify so in this case.
Material through Oh go ahead of us or refuse to file.
But it's like a CRL, but in this case, yes, we did receive our initial licensing milestone back.
We will pay that once its filed and submitted an accepted for review.
I've been in the business a longtime so I know things can go different ways that don't but people can expect so we try to incorporate some of the major.
Pivot points that could occur auto project. So that we protect ourselves we are small company, but we are committed to the relationship with some teleca, we highly value it.
The the refuse to file the product was based on.
I'll say, a minor formulation I'm going to call a minor because it is liner.
So we have to update the formulation, which means updating the batch record make some new batches show the new formulation and then refile, we expect that to be refiled. Shortly the rest of it the important stuff, which is the safety efficacy. The you know the rest of the aspects of the filing are a good order. So this is really us.
CMC, which again is not a showstopper, it's something that we will file we will get approval and we will launch a mixture.
Okay, and then just a quick question for Wilson.
Can you just give us a sense of what you expect the annualized running costs of the R&D lab and the headcount associated with that lab to be.
Well, we have 10 people at the lab, we don't normally a call out individual items for operating expenses for segments like that but.
There is some degree of detail that we show in our.
10-K, it sort of points to that so we don't normally call up lab separately individually.
We have 10 people in total devoted to the R&D function.
Okay. Thank you.
You're welcome.
Thank you.
Our next question comes on line of Frank Techar with Lake Street capital.
Hey, guys. Thanks for taking my questions. Just a couple of for you today are hoping to hear a little bit more about the by orphan launch so far if you're starting to see any repeat orders come through in the first quarter here and kind of how you're thinking about the personnel are you guys had in place with nearly 15% ourselves sales for.
Yes, and then if you guys got put some people behind that if that's going to be sufficient coverage for the.
4 million units you guys are targeting out longer term basis.
Yes, so a couple of points one.
We are I guess run up about we're getting reorders. So that's good that's a good sign.
Two we grow the institutions the number of customers every week, that's been going up.
You know three in terms of the sales team, we have confidence and accelerate to do and to handle that piece of it I think the key levers that will go forward and by the way we are smaller institutions, we're finding much easier to convert their fast conversions some of the larger institutions.
Which is really where the big volumes are just have a process in place and so they can be a couple of months before you start to really see the pull through coming through the large institutions, but we're confident it will happen.
We already have a few large institutions, but we're going to add more.
And which are lifecycle management of all later, introducing the vile, which we expect to have all within the next let's say 12 months.
We're getting a lot of people get a lot of traction on that I.
I think the key lever, which will certainly gross sales beyond our expectations will be.
Oh.
Really moving the Compounders off of this market works they shouldn't be anyways.
Got it.
Then.
For mm 100, I believe there was a one and a half million milestone fee associated with that upon approval is that still at play with the delay and is that expected on approval with that I'll put it today, it's or do you do for date I guess you call. It for August.
Yes, so it's still 1.5 million milestone upon launch of the product.
Got it alright, thanks for taking my questions and congrats on your first yourself.
Thanks, a lot.
Thank you.
Question comes from the line of Michael Bercy.
National Securities.
Yes, hi.
Just wondering how big it a little bit they probably missed by offering a situation.
You've got two things one is the FDA, obviously possible enforcement Cameroon, and then I think you mentioned.
That's a compound as some of the major competitors come come out of that.
Because of supply or whatever is that business going mostly to other compounded as though is that coming straight tier.
Oh, I think it's too early to tell on that one.
You know the the Calpine or is there a stubborn bunch are they really want to just do what they want to do.
The agencies have been trying to deal with them.
And it's not it's really about safety for patients and there's really no reason where you're.
Manually diluting and making products to be which are prone to errors versus a of room product that has been reviewed and for safety and efficacy by the agency. So.
You saw Pharmedium shutdowns one of the largest compound result, there.
This I can tell you that a common theme from the hospitals and from the customers as they are frustrated with supply disruptions.
So that is a selling point with regards to our product.
We are another big selling point as our three year shelf life. They like the even if they continue to buy from Compounders for whatever reason they like the concept of stocking order, where they can put our product in the hospital. They know they've got their for three years.
And they can use it as needed so.
Otherwise, they're having to make orders for federal upfront like every other week, which is just the logistics nightmare versus just making an order once a year or however, many times they need.
So the the appeal of the product drive sales first and foremost.
Two of the lifecycle management were relaunched the all the while in the surgeons in the new future will drive additional sales and convert that should convert people off the company product, even if the compounders didnt want to leave we believe and we've been told by hospitals. They will they will convert based on that alone because we're keeping our price points.
Similar there's really no cost savings to trying to use a compounded effect there opening themselves up to tremendous liability by customers who are affected by it only takes one customer to get the wrong dose and the FDA. His own of reports have shown that 30% of compounding products have the wrong potency. So yeah there.
As a potential legal issues that are involved for hospitals, even if they are trying to offload that risk by buying from third parties. So there's a lot of sales drivers on the product just by the quality of the product itself, but in conjunction we're doing our part on the regulatory in the legal side to.
Convert even a greater number of sales.
Our goal assuming that we.
We don't have we're not able to or the F. Two dozen exercise enforcement is still to hit 4 million units of the 20 million unit market.
We think thats achievable, just oh, all things staying more or less as they are a with a little bit of lifecycle management, we think that probably.
Oh, it could go much higher with the enforcement.
Right now the 4 million what does that convert tooling revenue roughly.
Well I mean in roughly if you're right now our prices about $10 an hour fuel hundred dollars. A box was TNMP is on a box.
So you're looking at a topline I guess would be 40, there's obviously a gross to not and there's some fees and things like that but let's just sort of easy math.
No.
Let's see Ftn force rank, what sort of teeth doesn't have as of.
Do they find them do they what do they do and if there was a fine as that money go to them all to you how does that work.
No it's not so much a fine it's a favorite typically this is all say my interpretation of it all but it's also my experience is not just my interpretation as they would receive a warning letter.
About ceasing to compound and if they continue to do that there could be subject of a consent decree.
And there's other actions, but they are they're not nice or they could shut down the comp powders.
The F.D.A. is a it's a government agency.
So good luck trying to.
Fight to go the U.S. government, which they're charter is a safety of Americans on their charter is to ensure that the drug supply is is there ought to treat patients and to do so in a safe manner.
Certainly when you look at and what happened the new England compounding situation people died because of all receiving non sterile and highly contaminated products.
You know you can look at.
Case studies out there on federal our foreign where there have been serious adverse events.
And that's.
You know, it's obviously evidenced as a balance if one looks.
Okay.
Probably the final part of it but.
You mentioned.
Sure.
Sure informing the compound isn't all that sort of thing all four of the FDA rule et cetera is there.
I am attempt to.
Inform.
The.
The buyers as opposed to the produce the suppliers and the D.F.D.A. also.
Go to the hospitals or whatever and say, how you're not supposed to be doing this stuff or how does that work.
Yes. So that's a good question. So we have primarily focused our communications to the suppliers.
The compounders and to the FDA, we will go to.
The customer and we will state that we have approval, we will stay at that because the pros of our product versus a compounded product, which are we ever longer shelf life, where we've been reviewed for safety and efficacy when you go to the customers.
Your restricted in a way on what you can communicate so you have to be careful how you frame that.
But ultimately yes, the customer a will receive communications, but we would pre review or whatever we communicate to the customer with the agency to make sure weren't full alignment.
Great. Thank you very much guys.
You're welcome.
Thank you.
Ladies and gentlemen, if you have a question. Please press star one on your telephone.
Next question comes from the line of Keith Gill with Carter, Terry and company.
Yes, good yet.
Taking my call I've two questions first would be of 81 on slide 13. Due date of March 17 will the FDA make a ruling on the drug itself approval or not approval.
Yeah, well they have a I mean, we had a previous press release, which stated DFT has asked us to complete.
This study a human factor study and so we had indicated in our press release that we cannot complete that study.
The next two weeks or so we're going to oversee the.
CRL communication from the agency do the study and make these other changes to the labeling that we've asked.
The labeling is quick that's easy to do the study.
We'll have we'll commence.
We'll submit the protocol of probably in the next week or two we ever validation protocol going to them.
After they have reviewed it will execute the starting on resubmit so them will.
It will be we believe the class one resubmission, which is a two month review time, which could give us approval and let's say the.
I'll, just say the fourth quarter.
And how long would just study take.
Oh it takes a week.
But the long part is not the study if I takes less than a week.
The long part is the F. T I take 60 days to review the protocol once we get that that we execute the study the study might have a.
Every two weeks for the report we submitted and then they start there are two month clock.
Thank you and I'm showing no further questions at this time I will now turn the call right.
The hedge on Brian Jellison for closing remarks.
Thanks, Andrew Lastly, I'd like to thank everybody for joining the call today.
I will say we remain very excited about 2020. This is a breakout and a big year for US we look forward to achieving our goal of advancing health care through the introduction of innovative medicines that are both affordable and available to all patients. It's an important mission to US. We also appreciate everyone's support and.
I will be providing further updates in the near future as we close any new deals and hit new milestones. So thanks again.
Ladies and gentlemen, this concludes todays conference call. Thank you for participating you may now disconnect.
[music].