Q4 2021 Vanda Pharmaceuticals Inc Earnings Call
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Ladies and gentlemen, and thank you for standing by and welcome to the Q4 2021 Vanda Pharmaceuticals, Inc. Earnings Conference call. At this time, all participants are in a listen only mode. After the speaker's presentation, there will be a question and.
Answer session.
I'll ask a question during the session you will need to press star one on your telephone keypad. Please be advised that today's conference call is being recorded.
If you require any further assistance. Please press star zero I would now like to hand, the conference over to your speaker today, Kevin Moran Vanda Chief Financial Officer. Thank you. Please go ahead.
Thank you Cherry.
Good afternoon, and thank you for joining us to discuss Vanda pharmaceuticals fourth quarter and full year 2021 performance.
Our fourth quarter and full year 2021 results were released this afternoon and are available on the SEC's Edgar system and on our website Www Dot Vanda pharma dot com.
In addition, we are providing live and archived versions of this conference call on our website.
Joining me on today's call is Dr. Mahalo spine Europolis, our President Chief Executive Officer, and Chairman of the Board, Jim Williams, Our General Counsel and Secretary.
Gunther beers mix, our senior Vice President of business development, and R&D Committee member an independent expert Dr. Thomas <unk> from the University of Louisville.
Following my introductory remarks also update you on our ongoing activities.
And then comment on our financial results before opening the lines for your questions.
Before we proceed I would like to remind everyone that various statements that we make on this call will be forward looking statements within the meaning of federal securities laws or forward looking statements are based upon current expectations and assumptions that involve risks changes in circumstances and uncertainties. These.
These risks are described in the cautionary note regarding forward looking statements risk factors and management's discussion and analysis of financial condition and results of operations sections of our annual report on Form 10-K for the fiscal year ended December 31, 2020 as updated by our subsequent quarterly reports on Form 10-Q .
It reports on form 8-K, and other filings with the SEC, which are available on the SEC's Edgar system and on our website.
Additional factors may be set forth in those sections of our annual report on Form 10-K for the fiscal year ended December 31, 2021 to be filed with the SEC in the first quarter of 2022, we encourage all investors to read these reports and our other filings.
The information we provide on this call is provided only as of today and we undertake no obligation to update or revise publicly any forward looking statements. We may make on this call on account of new information future events or otherwise, except as required by law.
With that said I would now like to turn the call over to our CEO , Dr. Mcauliffe polymer Atlas.
Thank you very much Kevin and good afternoon, everyone.
I appreciate you joining us to discuss our fourth quarter and full year 2021 results as well as our phase III Gastroparesis results and proposed next steps in our development program for it to a dividend.
As usual I will discuss our commercial performance and the highlights of our clinical development programs and then I will turn specifically to the Gastroparesis study and predicted.
We continue to see strong interest with new patient prescriptions, especially for sighted patients with non 24.
However, we also saw a significant increase in the rates of payer denials for sighted patients with non 24.
Led to a net decline of non 24 patients.
We will discuss in more detail our significant efforts to support patients with non 24 and the progress we're beginning to make.
Basically for Medicaid insured patients.
We launched <unk> and <unk> L Q4, the indication of nighttime sleep disturbances in patients with Smith <unk> syndrome.
More than 50 patients with SMS are currently on treatment and more are awaiting payer approval.
We're working closely with advocacy organizations and direct to consumer campaign to increase awareness around Smith <unk> syndrome.
We recognize that many patients with SMS remain and diagnosed and are currently treated for various neurodevelopmental disorders.
Through our genetics platform, we have recently discovered that up to 100000 patients diagnosed with autism.
Syndicated potential of genetic mutations in the RT I want gene, which is often deleted or mutated in patients with SMS we.
We believe that this discovery will aid in the molecular identification of patients with SMS and long the autism population of patients and offer them a new therapeutic solution.
We look forward to beginning to resolve the access hurdles for sighted patients with non 24 <unk>.
Expanding our SMS populations treated patients and advancing the heck years through the clinical program of delayed sleep wake.
Disorder.
We're pleased with the settlement with one of our circulars and defendants and look forward to a surgeon or if it is franchise against the remaining defendants in the upcoming trial.
On Fanapt, we're making progress in our phase III study bipolar disorder, which is now over 50% enrolled and expected to complete enrollment by the end of 2022, well the olopade the long acting injectable program is advancing.
Yes.
I will now turn to our recently announced completion and results. So far it's the deepest in Gastroparesis study and offer some more insights and discuss our planned future direction for this program.
We recently reported initial results from the.
So dividend clinical study in Gastroparesis.
In a prior phase two clinical study.
The dividend was shown to improve a host of symptoms in patients with gastroparesis, including nausea and vomiting.
Prior phase two study had a four week duration and enrolled approximately 150, idiopathic and diabetic gastroparesis patients with moderate to severe nausea.
These patients were randomized one one to one entre Gibson or placebo.
The recently completed phase III study enrolled the same patient population.
And featured two study design differences from the Phase II study.
Because we observed a large effect size of response among patients with at least one vomiting episode in the prior phase II study.
Patients with no reported bond connect usage during screening we excluded from this phase III study.
Additionally to meet FDA guidance, we increased the savvy duration from four to 12 weeks.
The first inside the enrolled approximately 200 patients were randomized one one and received her deep thunder or placebo.
The study had a prespecified primary statistical endpoint.
Oh Daily Diary reported subjective nausea severity change at week 12 from baseline.
Beyond the primary endpoint other outcomes included evaluation of other symptoms of Gastroparesis, including vomiting, Retching bloating fullness abdominal pain.
In addition to the daily diary evaluation patients also reported that regular intervals. There overall impression of improvement in a six point scale ranging from very much improved to no change very much worse.
This scale acronym is P. G I see a patient global impression of change.
Patients also reported similar changes towards each of the core gastroparesis symptoms and a weighted overall improvement score was calculated according to pace our reported ranking of symptoms at baseline referred to as overall patient benefit.
Patients who are allowed to use certain rescue medications during the course of the 12 week study.
Common study design option and similar to the fireside.
Appointment blinding, we observed first an imbalance of baseline use of rescue medication.
With more rescue medication use in patients, who eventually randomize to triptans.
We also observed a much higher use of rescue medication at baseline in this study as compared to the prior study.
An imbalance of baseline severity was also observed with higher baseline knows the severity in the <unk> group.
Hey, regular pharmacokinetic analysis shampoo.
Sampling also revealed that a number of different pieces, we're not compliant with therapy.
When the restricted the study analysis to the population of patients who use no rescue medication and were compliant with treatment, we observed a significant and meaningful effect across most of the core symptoms of gastroparesis.
Firming the results of the prior four weeks study.
We have continued to analyze the data and identified a host of factors pointing to a large placebo response with his confounded the data overall.
Placebo responses of therapeutic response to anti nerve treatment in the course of a clinical study.
Placebo response has been observed at almost every clinical studies Sydney and in particular in those studies, where the therapeutic outcome is subjective.
As such large placebo responses are common in clinical studies of psychiatric conditions, including depression pain.
Pain studies and studies of therapeutics of gastrointestinal disorders.
The observed placebo response has plagued clinical studies for decades, and it reportedly appears to be getting larger over time.
The growing scientific literature is attempting to address and understand the issue by characterizing the common and potential confound is leading to placebo response.
Placebo response has been attributed to a host of factors that include trial design population selection and sadly endpoint issues.
It will understood factor contributing to placebo response is a baseline symptom severity in places.
Where did they report that baseline symptom severity is inflated leading to subsequent improvements while patient symptoms actually just return to the undisturbed baseline.
Another factor is related to patients expectancy or anticipation of a much desired symptom improvement study.
Study site variability such as the possibility of sighting CT incident also may contribute to improve placebo responses during the trial.
Ciao design issues, including length of screening period and length of study are also correlated with placebo responses.
In a study of response rates and Ozier.
Studies, a significant increase in placebo response rates was correlated with length of study, where Saudi is longer than two weeks. So at extraordinary rates of placebo response as high as 72, 8%.
Given these observations demonstrating a therapeutic effect above and beyond that of placebo becomes exceedingly difficult.
Moreover, quote unquote negative studies of new therapeutics could simply be false negatives, where the person therapeutics has a therapeutic effect, but not significantly larger than the placebo response.
This issue constitutes a major question of large public health significance.
If placebo responses mass can be effectiveness of drugs during clinical studies important new therapeutics may be precluded from coming to the market Harman patients and leading to tremendous social economic costs.
During this initial evaluation of our face beside the results and in response to the large placebo effect seen in this study Vanda has developed an analysis approach that aims to reduce the placebo effect and a law.
A better estimate of the two treatment effect.
A baseline severity inflation is a common factor cited as a driver of placebo response.
This study would be particularly susceptible because it's a very good vessel was prespecified for Nokia as well as a medieval castle for vomiting.
Well. These thresholds are meant to enroll patients with adequate severity court less prone to continuous improvement during the study. We can also inflate the reported baseline severity.
According to the principle of migration to the mean patients with inflated baseline severity are likely to experience improvement regardless of treatment assignment, leading to a significant placebo effect.
We have developed a buzzword to adjust for possible baseline severity inflation.
When adjusting for baseline severity inflation or BSI and.
And introducing B aside is it parameter in the statistical model.
We observed a significant interaction between baseline severity inflation and treatment.
So that did decrease of treatment on clinical outcomes is different between different groups of patients.
According to their BSI status.
Patients were reclassified in two classes of high or low BSI basins with low BSI showed a robust treatment effect across most of the clinical outcomes, including the patient reported core symptoms of gastroparesis in the pre specified.
Endpoint of nausea severity at week 12.
Significant improvement was also observed across the global impression scale.
<unk> reported global impression of change.
And the overall basin benefit evaluation.
Well, we're continuing devaluation of the study data we believe that the evidence produced so far constitutes a substantial evidence of efficacy to support an efficacy claim for treatment in the treatment of patients with Gastroparesis.
The statutory substantial evidence standard is inherently flexible.
Generally requires sufficient evidence that a reasonable mind, considering the record visit hull might accept is adequate to support the conclusion, even though other reasonable persons may disagree. This is less demanding than the other evidentiary standards such as preponderance of the evidence.
It is important for the F D a industry and academia to work constructively with drug innovators to ensure that tools like placebo control unemployed thoughtfully with consideration and development of new designs and analytic tools to account for the placebo.
Once rates and do not close the abandonment of effective therapeutics.
Treatment for Gastroparesis is an unmet medical need which has not seen any significant therapeutic innovation in 40 years.
It is important that we acknowledge and overcome methodological challenges and being new drugs to patients as soon as possible.
We believe that the current clinical study designs required by the F. D. A regulatory approval in Gastroparesis are especially prone to large placebo responses, which can effectively impede the discovery of any new therapeutic.
This has been true for a number of promising drags in Gastroparesis, which have shown initial effects in four week studies, but failed to separate from placebo in longer 12 week studies, where very large placebo response rate we're seeing.
Besides the placebo response effects. It is important to recognize that these clinical programs are not experiments that can be easily repeated given extraordinary recruitment challenges.
Despite diligent enlarge advertisement efforts the three dividend program, who has taken over six years to recruit approximately 350 patients into randomized placebo controlled studies.
We believe it is imperative that we use the existing evidence to inform the regulatory approval of new drugs, including the dividend.
For the community of patients with Gastroparesis, we believe that our proposed approach may bring a host of new innovative treatments forward, which have been already tested in adequate and well controlled studies, which however failed to meet their regulatory prespecified endpoint for the reasons discussed above.
But for which the totality of the evidence would satisfy the regulatory standard of substantial evidence of efficacy.
Moreover, we believe that the adoption of our analytic approach could ASUR, a new era of therapeutics, especially in resources that depend on subjective pace and reporting and were placebo response rate and exceedingly high including depression pain and other gastrointestinal disorders.
Beyond novel analytic tools researching new trial designs should be investigated and FTE guidance with development of drugs in these indications should be revisited.
Vanda intends to collaborate with the FTA underscoring the need for a view of the dip them in accord with the calibrated standard that Congress.
Specifically enacted.
We hope that the FDA will work cooperatively in a search and the appropriate application of the substantial evidence standard in this context.
I will now turn the call over to cut their business to introduce Doctor up.
Okay.
Thank you my house with that I want to introduce Dr. Thomas Abel.
A professor of medicine at the University of Louisville, and the Arthur Am shown M. D Chair in Gastroenterology Doctor able has expertise in gastrointestinal motility, Gastroparesis and endoscopic device development. He was an investigator in both a band does pay.
As two and phase three Gastroparesis studies and as a co author on the phase two manuscript published in 'twenty 'twenty titled.
I can see and safety after dividend in patients with diabetic and idiopathic gastroparesis in a randomized placebo controlled trial.
He is joining us today to discuss why increasing the length of studies in Gastroparesis to a 12 week period may affect outcomes in Gastroparesis studies and the impact on the placebo effect Doctor able I will now turn the call over to you. Thank you.
Thank you.
This is Tom legal or Gi Doctor in Kentucky with University of Louisville.
As mentioned earlier I was in the two previous studies as an investigator.
I wanted to mention again or not a consulting kind of new stock in vanda.
And the opinions here my own based in 40 years of research and practice.
Our clearly cure protecting specialize in patients that were <unk>.
Like those in the past to van studies and our team sees several hundred new patients like this every year.
These patients are often quite hill.
From Gi complaints, including chronic nausea, and vomiting, and often have disorder gastric emptying.
Sometimes we think we know the reason for that is sometimes including disorders like diabetes. Other times, we don't know Ricardo Seely Patrick Gastroparesis.
<unk> recorded by standardize scales called patient reported outcomes through bureaus and one of those was used for the study.
What was discussed today was the latest study <unk> a drug that involves blocking NK one receptors.
Its newest study and the previous study compared the active gun to conceive over an active drug.
This newest study differed from your previous study and it was for 12 weeks, which was much longer than the previous study.
That's what the first study the primary endpoint with severity of nausea, using a standardized patient outcome.
And there were additional symptom measures.
Since that had been mentioned.
One of the issues is a weeks of the study and our experience. It does not take 12 weeks no medication will work in this population.
Often a matter of weeks for example, four weeks is enough to see that effect.
Related issue is a patient in the study were moderately to severely ill and many patients depend on rescue medications to enable them to stay in the study.
I wish I could convey how LDC guar.
Ah patients and.
Yeah.
Poor quality of life and are often jesper.
Most individuals had to experience nausea, and vomiting briefly with a flu like illness that image.
Living like that every day.
There's not a lot of options for these patients.
A study of 12 week duration, they make it hard for some of these cases to continue, especially if they're receiving placebo.
As concerned about Lincoln Studies has been previously mentioned by several of my colleagues nationwide and communicated to groups involved in designing studies for this population.
Well 12 weeks may be satisfactory with patients for some Gi disorders, such as the irritable bowel syndrome. It may not be optimal duration for patients with gastroparesis and related disorders.
Well it was concerning that the study did not meet includes as described we were interested in the role that excluding some areas like rescue medication and compliance may have when we analyze the data.
The other factors, which we've heard with will emerge on further analysis of the data from this study.
The need for effective and safe medications to this group of gastric patients.
Patient whose related conditions remains high.
The study presented today shows promise, but the results presented raised questions as to what is amongst effective study design.
Clearly the duration of the study.
Those of US who see these patients are hoping there Chris and other medications can forward towards FDA approval.
Thank you.
Thank you very much Dr April .
I'll now turn to discuss our financial results for the fourth quarter and full year 2021.
I'll begin by summarizing our full year 2021 financial results before turning to discuss the fourth quarter of 2021.
Total revenues for the full year, 2021, or $268 7 million, an 8% increase compared to $248 2 million for the same period in 2020.
U S net product sales of $173 5 million for the primary contributor and driver of our 2021 revenues and saw 8% growth compared to 2020.
The year over year growth of the U S business was driven by net price favorability, partially offset by lower unit sales, primarily as a result of increased payer resistance to heavier coverage.
Net product sales of $95 1 million for the full year 2021 reflect 9% growth compared to 2020.
For the full year 2021, Vanda recorded net income of $33 2 million compared to net income of $23 3 million for 2020 .
Net income for the full year 2021 included an income tax provision of $9 2 million as compared to an income tax provision of $8 3 million for 2020.
<unk> cash cash equivalents in marketable securities referred to as cash as of December 31, 2021, or 432.8 million, representing an increase of $65 1 million compared to December 31 2020.
Turning now to our quarterly results.
Total revenues for the fourth quarter of 2021 were $68 million, a 1% increase compared to $67.7 million for the fourth quarter of 2020.
<unk> net product sales were $44 1 million for the fourth quarter of 2021 compared to $44 2 million for the fourth quarter of 2020.
Snap net product sales in the fourth quarter of 2021 or $24 million.
2% increase compared to $23 5 million in the fourth quarter of 2020.
Net product sales in the fourth quarter of 2021 decreased by 2% as compared to $24 5 million in the third quarter of 2021.
Fanapt prescriptions in the fourth quarter of 2021 as reported by equivalent exponent decreased by approximately 2% compared to the third quarter of 2021.
For the fourth quarter of 2021, Vanda recorded net income of $7 1 million compared to net income of $8 2 million for the fourth quarter of 2020.
Net income for the fourth quarter of 2021 included an income tax provision of $1 5 million as compared to an income tax provision of $2 7 million for the same period in 2020.
Operating expenses in the fourth quarter of 2021 were $59 4 million compared to $57 2 million in the fourth quarter of 2020.
The 2.2 million increase was primarily driven by higher R&D expenses related to the late stage Fanapt development program, partially offset by lower SG&A expenses, primarily related to awareness and branded DTC campaigns.
Operating expenses in the fourth quarter of 2021 were essentially flat as compared to $59 3 million in the third quarter of 2021.
Vanda expects to achieve the following financial objectives in 2022.
Net product sales from both years and Fanapt of between 240 and $280 million.
<unk> net product sales of between 150 and $180 million.
Fanapt net product sales of between 90 and $100 million.
Year end 2022 cash of greater than $440 million.
Our 2021, <unk> net product sales performance and our 2022 heaviest net product sales guidance reflect the continued and significant increase of reimbursement challenges from payers to fill prescriptions for patients with non 24. However.
However, demand continues to far exceed the prescriptions filled and vanda continues to work with patients in an effort to improve their access the only FDA approved treatment for their condition.
We expect these reimbursement challenges to impact the near term performance, we remain optimistic and excited about the longer term forecast.
As Tim will detail in a moment, we've made significant progress in the past quarter I'm beginning to resolve payer challenges and particular with state Medicaid programs and we are looking to develop and deploy strategies that we're hopeful will lead to similar improvements with Medicare and commercial plans.
We are in the early stages of commercial launch for <unk>, and SMA and the payer reception to patients with this indication has been much more positive.
The lower end of the heaviest net product sales guidance range assumes a continuing net decrease in patients on therapy, primarily due to payer challenges.
The upper end of the guidance range assumes a net increase in the patients on therapy driven by resolution on some of the payer challenges and growth tied to the continued launch of <unk>.
We expect first quarter 2020, Q U S revenue to be impacted by the annual Medicare manufacturer contribution and the annual payer disruption linked to new plan years plan changes and re authorizations, which we have seen in prior years.
While we don't provide quarterly revenue guidance, we want to highlight that typically the first quarter of the year is the most challenging quarter and historically represents approximately 22% of annual <unk> net product sales.
While we acknowledge the continued payer challenges heading into 2022, we are optimistic about the future for <unk> in both current and future indications.
We expect both R&D and SG&A operating expenses to rise in 2022 as compared to 2021 spending levels.
The primary contributors to the expected 2022 growth in spend include R&D activities related to our late stage clinical programs and commercial programs for Fanapt and yes.
We expect to continue our trend of adding to our cash balance while advancing our portfolio of investments in support of patients.
With that I'll now turn the call over to Tim for an update on payer challenges.
Great. Thanks, Kevin.
Asthma Holliston, Kevin both mentioned.
We're continuing to address reimbursement delay anything improper denials for heavy transportation.
We've made significant progress in the past quarter, particularly with state Medicaid programs.
In November of last year, Atlanta patient file a federal lawsuit challenging, Colorado, Medicaid prior authorization criteria, which limited coverage to totally blind patients.
In response to this lawsuit, Colorado properly change its criteria to cover <unk> for all non 24 patients and to no longer restricted we have coverage on the basis of condition status.
Following this lawsuit Vanda recognized 18 other states with a similar restriction and requested immediate coverage changes in those states.
Since that time 10 of those 18 states have revised their criteria to eliminate the blindness requirements include.
Including Florida, Pennsylvania, Ohio, North Carolina, Michigan, Maryland, Oklahoma.
Our West, Virginia, and most recently, Wisconsin.
Of the remaining eight states four more states have agreed to discuss their criteria at upcoming drug review committees. These include New York, Minnesota, Nevada and Alaska.
The remaining four states are actively reviewing our request and these include Georgia, New Jersey, Mississippi in Vermont.
In addition to this Medicaid activity, we're continuing to develop strategies to challenge similar Pedro criteria with Medicare and commercial plans and hopes of securing access for all non 24 patients regardless of mutation status.
With that I'll turn the call back to the policy.
Thank you very much team at this point, we will be happy to answer any questions you may have.
As a reminder to ask a question you will need to press star one on your telephone did withdraw. Your question you May press the pound key please standby, while we compile the Q&A roster.
Your first question comes from the line of Chris Howerton from Jefferies. Your line is now open.
Hey, thanks, so much for taking the questions.
I guess the two from me would be with respect to the revenue guidance that you provide for next year.
Do you anticipate any more price increases are in calendar year 2022, I'm sorry, if I missed that if you already said something Kevin I apologize.
And then the second question that I would have is.
Maybe for Mahalo is dead.
You know, what what would be kind of the expectation of palatability of kind of the baseline.
Adjustments that you're kind of proposing here has this been discussed in the past.
You know it would there be certain kind of champions internally at the FDA that that shared this view point that its very important to control for these things.
Thank you.
Sure. Thanks, Chris Kevin do you want to take.
The first question I'll take the second.
Yep Yep no problem. So yes, Chris just to clarify you said any more price increases in 2022, so we haven't taken any price increases in 2022 and.
It's something that we obviously continually monitor and evaluate based on facts and.
Cancers, but nothing that we communicated as planned at this point.
That's clear okay. Thank you increase.
Okay and could I understand your question to be.
If we propose to adjust for these baseline severity inflation.
And then.
Look at the results under that prism.
Who would be receptive to that well first of all.
The a large community of experts.
Has discussed in the literature these approaches, especially in the context of.
Failed studies quote unquote failed studies in depression.
And have recognized that baseline severity inflation.
Is something very real.
It is something that's been repeated in clinical studies and something that.
Must be adjusted then control.
Specifics on adjustments and cutoffs have been discussed in major depression, we're a lot more therapeutics and loved studies being developed.
However.
This is not a new proposal.
The proposal that when you specify when you gotta inclusion criteria a certain degree of severity that these may lead to baseline inflation is actually well established across many indications.
Our proposal is to correct for that if there is a true interaction between baseline severity.
And Cleveland effect, well the concept of statistical interaction is not new at all has been described in the statistical literature for.
Over 50 years. So the concept there is that.
The expectation of the planes statistical models is that the effect of the treatment would be linear across S. E T.
Continue.
But that is not always too and there will be circumstances, where.
At the bottom or at the very top of the baseline severity because of inflationary pressures the effect may be looking different so what I discussed then of course, we've been up with all these publications in peer reviewed journals is that we observed a statistically.
Significant interaction between baseline severity inflation and treatment effect this actually.
It gives us the license and the obligation to look for sub populations that would have benefited and the sub population of course is the one with a low baseline inflation.
When we look in that population of patients there.
Then the study.
So there is significant evidence across a number of symptoms as I said, including the primary endpoint and also across the <unk>.
Entire set of patient reported outcomes of overall.
Overall benefit, but also individuals' symptom severity.
Another part of your question was would there be champions of the F D. A.
We hope so right of course, we don't know that and we hope so for the benefit of patients and.
As I was discussing in my script.
This is a major issue of public health.
Significance.
Inside the FTA over many years has done a great job weeding out.
False positives drags that may appear do you have an attack, but actually they don't have the effect.
And while they have optimized their tools will be here to do that.
This many times is being done at the expense of the false negative we know of no FDA guidance that.
Actually discusses how to deal with placebo effect, well placebo effect is real.
And it is confounding.
Many thousands of cells.
Many folks like yourself that have covered.
Companies that develop psychiatric drugs like drugs in major depression.
You'll note that there is a common theme that we need to run two or three studies to get one positive right, but that should not be happen. This is not chase.
Chase in a way we should be gambling.
To find and effects of the drugs.
Yeah, I mean, I I hear Ya I guess you know my.
Whenever I don't have to respond.
Yeah, no that totally makes sense and.
I guess one other question that I would ask with respect to the trip. It in kind of program moving forward would you wait for kind of feedback from regulators on kind of the status of the current clinical package or.
Are you planning on embarking on additional clinical studies be prior to that.
Yeah.
Certainly it is too early to answer. This question all I can say, we're committed to being too dependent to.
To the market.
And of course, we cannot do that ourselves, but they have to be.
Very involved discussions with regulators, but also with experts because the experts are the ones who.
Being this information to the regulatory agencies now in terms of.
Can we do additional clinical experiments, where actually we can advance and confirm the pieces that we're developing.
Potentially yes.
But of course, we need to develop these designs so the.
The design as I said that the F T a hasnt.
It Hasnt dairy guidance of for development of drugs of Gastroparesis.
Acquires a 12 week study.
And also it requires that you pre specify one of the symptoms as a primary endpoint.
Well you heard from our Doctor able today about the concerns across.
An entire set of experts in the literature and actually voice to the FDA that the 12 week study.
Is not very workable for many reasons.
But also there are other elements as I said space find the primary endpoint is one symptom change of nausea safety from the baseline may not be reflective exactly how.
These drugs work and what the patient need and I don't think the simple answer is pre specified endpoint get the P value less than 0.2 to five and only then you have a drug I think these kind of monolithic approach may be actually hurting the development of new drugs.
Including drags for Gastroparesis.
And I think that many many patients recent.
Recently, another company's drug failed to meet the primary endpoint at 12.
Week study, where it has succeeded in a four week cited for Gastroparesis. This drug was discontinued and so it was another one.
So it is very likely as I said and that's my hope on behalf of the Ah.
Patients in developments in this field that all of these drugs are being revisited and the approach of bad day staking.
It becomes a license to take another look and for the F D a and regulators to actually rethink what I call. A monolithic approach can drive development of this very very much in need a piece of populations.
Okay, Alright, that's very clear and I appreciate it okay well. Thank you my house and thank you for taking the questions.
Of course, thanks, Chris.
I am showing no further questions at this time I would now like to turn the conference back to Vanda management.
Yes, thank you very muscle.
Joining us and your interest in Vanda and we'll talk to you soon thank you.
Ladies and gentlemen, this concludes today's conference call. Thank you all for your participation you may now disconnect.
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