Q2 2022 Provention Bio Inc Earnings Call
To launch planning Investor event.
Well as relevant updates.
Before we begin let me remind you that the various remarks, we will make today constitute forward looking statements.
These include statements about our future plans and expectations.
Clinical results regulatory and other developments and timelines related to our product candidates, including.
Including our plans to continue working with the FDA as they review, our BLA Resubmission and continuing our efforts towards securing a potential FDA approval for and commercialization of <unk> mab for an at risk indication.
As well as the planned delivery of significant catalysts over the next 24 months.
The potential safety efficacy and commercial success of <unk> and our other product candidates.
Potential COVID-19 impact on our clinical studies and business plans.
Financial projections, including our anticipated use of cash and our cash runway.
And our business plans and prospects and projected timing for the same.
Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors.
Including those discussed in the risk factors section of our most recent quarterly report on Form 10-Q.
We filed with the SEC this morning.
And in other filings that we may make with the SEC in the future.
Any forward looking statements represent our views as of today only.
While we may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views change except as required by law.
Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today.
There is more complete information regarding forward looking statements risks and uncertainties in the reports prevention files with the SEC.
These documents are available on prevention web site at Www prevention bio dot com under the investors section.
We encourage you to review these documents carefully.
With that I will now turn the call over to Terry.
Thank you Bob.
Before I begin discussing the financials for the second quarter.
I'd encourage you to read our 10-Q that was filed today.
The 10-Q includes our financial statements risk factors as well as management's discussion and analysis.
Our financial condition.
I would also like to call your attention to the earnings press release, which was issued prior to this call.
Let me start with our current cash position and cash projection.
As of June 32022, our cash cash equivalence and marketable securities position was $96 1 million.
This includes net proceeds of $11 $1 million generated through our aftermarket or ATM program during the second quarter of 2022.
We have currently approximately $130 million remaining capacity on our ATM.
We will continue to be opportunistic on the use of this program.
Also following the regulatory update we provided in early July .
We completed a private placement with two of our shareholders.
The transaction brought in net proceeds of approximately $57 $2 million.
Which will support our preparation towards a potential launch of depletion.
In the same prudent manner in which we are we have been operating.
This additional cash generated from the private placement is not included into the cash figure I cited for June 30.
And we will be reflected in the third quarter financial results.
Our cash based operating expenses for the first quarter ended June 32022 were $27 2 million, which excludes noncash stock based compensation of $3 $2 million.
And depreciation expense of <unk> 2 million.
This number came below the lower end of our guidance.
Given by a prudent approach to expenses and cash management.
We expect our cash based operating expenses to be between 27 and $31 million in the third quarter of 2022, reflecting a slight increase in program spend and launch readiness activities as we prepare for the potential FDA approval of the Piedmont in Q4 2022.
Based on our current business plan, we believe that our cash cash equivalence and marketable securities on hand inclusive of the proceeds from the private placement will be sufficient to fund the company's operating requirements for at least the next 12 months from the issuance of these financial statements.
Is the depletion liabilities accrued this guidance would be impacted by changes to estimated costs of commercialization and potential milestone payments.
In a scenario where the approval for depletion maybe not obtained from the FDA in November .
We estimate that our cash runway will extend through 2023, which is beyond the top line data readout from the <unk> phase III trial in newly diagnosed <unk> patients.
We expected in the second half of next year.
We believe our momentum with the potential approval of the <unk> later this year.
<unk> with Optionality to raise capital and we will continue to be both strategic and opportunistic when evaluating potential financing alternatives.
Evidenced by the most recent private placement.
We will provide updates on our immediate cash based expenses and cash runway as we progress towards the potential regulatory approval and commercial launch of the PRIZM up and continue to position ourselves for long term success.
Moving to the P&L we.
We generated a net loss for the second quarter of 2022 of $29 7 million or <unk> 46 per basic and diluted share compared to a net loss of $29 1 million or <unk> 46 per basic and diluted share for the second quarter of 2021.
R&D expenses were $16 $6 million for the second quarter of 2022.
Compared to $17 million during the same period in 2021.
The decrease year over year was driven by lower costs for the company as the plasma program.
Including the protect study as target enrollment was reached in August of 2021, and lower regulatory costs compared to the prior year.
R&D cost decreases were partially offset by increased costs associated with the enrolment of the proactive and pre Val <unk> trials for <unk> and <unk>, 30% to 79, respectively.
As well as increased manufacturing costs for commercial batches of depletion.
G&A expenses were $14 million for the second quarter of 2022.
Third to $13 2 million in Q2, 2021, driven by an increase in our pre commercial activities.
During the second quarter, we also recognized $7 million of collaboration revenue under our license agreement with <unk>.
With that update I will now turn the call over to Ashley.
Thank you Terry and good morning, everyone.
Throughout the second quarter.
Our team has continued to collaborate with the FDA in support of our resubmitted tactless Demob BLA for the delay of clinical type one diabetes in at risk individuals.
In mid June we received an information request from the agency.
Asking for are jointly developed population PK model to be revised to include the most up to date anti drug antibody data in case it might affect the proposed adjusted dosage regimen.
We promptly updated the model.
The antidrug antibodies do not significantly impact either the output of the model or any corresponding adjustment to dosing regimen for exposure matching purposes.
By the end of June we received notification that the agency would be treating the update as a major amendment extending the action date for its ongoing review.
Three months to November 17th of this year.
While this is extremely frustrating for our company and its stakeholders, especially the tier one the patients and families. We serve who have waited so very long for a disease modifying therapeutic option.
We believe the extension does bring with it good reason to be optimistic about the prospect of ultimate approval.
Wireless scenario in which the FDA does not approve our BLA, but instead issues a second CRM remains possible.
It is our understanding that it would be unusual for the agency at the point. This close to the original August 17th action date to request more time just to say now.
We believe that it is more likely that the <unk>.
<unk> is seeking additional review time to be able to say yes.
Indeed, the fda's guidance stipulates that except in rare circumstances.
A decision to extend the review clock should be limited to those occasions. When additional review time could lead to approval within the current review cycle.
We are committed to collaborating with the agency to support its ongoing review and remain hopeful and optimistic that this coming November we'll see prevention bio well positioned to potentially bring the first ever disease modifying therapy to individuals in.
In the United States.
Risk of developing clinical stage type one diabetes.
Up to this point have had no option available to them other than a lifetime of insulin therapy with all of its inherent challenges concerns and complications.
I will now hand over the call to Jason to summarize our launch preparations, which he and his leadership team presented during an investor event focused on commercialization that we hosted last quarter.
Jason.
Thank you Ashley and good morning, everyone.
Again, thank you to all of you who tuned in to the commercial Investor event, we hosted on May 19.
At the event, we spent 90 minutes highlighting our preparations for the potential launch of daclizumab for patients at risk of developing clinical stage one day.
For those of you who have not yet had the opportunity I strongly encourage you to listen to the replay which remains available on the investors page of our corporate website.
In addition to presentations made by our commercial leadership team. We were honored to be joined by key opinion leader Kimber Simmons from the Barbara Davis Diabetes Center at the University of Colorado in.
In addition to providing her insights on both the current patient screening approach along with her thoughts on how this may evolve in the future, particularly if a treatment for early stage <unk> is available in.
In addition, she highlighted the preparations that are being made in Colorado for a potential approval of <unk>.
During the event, we provided overviews of our progress toward launch readiness, focusing on key functional areas, including medical affairs marketing sales, including our go to market strategy and deployment model and finally market access comprised of payer strategy and efforts to secure access.
We also discussed some key insights gleaned, primarily those derived from quantitative market research, including health care provider and tend to prescribe patient likelihood of accepting treatment if prescribed by their physician as well as a health care provider and consumer screening and 10, if daclizumab is approved for stage two tier one day.
On the market access and distribution side of things, we continue to make good headway and progress toward launch readiness.
As reviewed during Investor day payer feedback through individual meetings focus groups and market research has been quite positive regarding the response to daclizumab and the potential benefit it could bring to this area of significant unmet medical need.
Similarly in pricing research, where typically payers, who are blinded to us an anonymous are the most critical and negatives. We received incredibly positive feedback payors key opinion leaders and health care providers, all perceive high unmet need in type one diabetes, especially for stage two patients based on this research.
When the target product profile for <unk> was introduced in the participants were asked to ranked a pleasant maps perceived clinical benefit of meeting that unmet need on a scale of one to five with one being no benefit in five of the major benefit.
<unk> gave daclizumab, a $4 five which is impressive on its own.
Payers, even more astoundingly in my opinion gave daclizumab a $4 two.
For payers to ranker product above four is rarely seen in blinded market research and reinforces just how important treatment with daclizumab will be perceived.
While we're not a gene therapy or a cure for established and stage <unk> ratings. This strong are usually reserved for those such products in the opinion of our market research providers.
When asked for pricing benchmarks those are payer would on their own think of when they think of a price point comparator for it to play them that they really couldnt come up with that.
The good news was insulin was not in their minds as a competitor.
In addition to the payer work all government programs and price reporting policies continue to be on track to support an approval. We shared the core elements of the limited distribution model. We've designed a key goal of which being to provide options with respect to site of care, including our two network specialty pharmacies that have home infusion capabilities in all 50 states.
And reduce as many barriers as possible that come with a 14th consecutive day infusion.
In addition, we shared the development of our patient services program branded as Compass.
Designed to compliance reduce barriers to physician and patient access through elements like benefits investigation copay support for eligible patients and infusion training.
Lastly, during the presentation, we introduced our plans for building a field force to support the launch of Daclizumab, which began with our eight person pilot team alongside our sales leadership team.
This team will scale up to 60 sales reps following a potential approval.
As we noted during our presentation. Our intention initially was to begin providing conditional offers to potential candidates around now.
However in light of the delayed review timeline, we will continue the recruitment process and ship the conditional offer timing closer to the new action date with the goal of bringing the entire team on by the end of the year.
Our team continues to utilize this time to have focused conversations around disease awareness and screening for early stage <unk>, while simultaneously dotting all the i's and crossing all the Ts with respect to launch readiness and plan to launch to put them out as quickly as possible after a potential approval.
With that let me turn the call back over to Ashleigh ash.
Thank you Jason.
Throughout the last quarter, our team continued to make progress across all of our priority autoimmune disease focused clinical development programs.
Including <unk> for newly diagnosed <unk> patients in our phase III protect trial.
<unk> $32 79 for systemic lupus arithmetic.
The ongoing enrollment of our phase Iia prevailed two trial.
As well as our Amgen partnered anti IL 15, monoclonal antibody or the circular being studied for nonresponsive celiac disease in phase two be proactive trial.
We also continued to engage prospective partners with respect to the ongoing development of our <unk> 101, Polyvalent Coxsackie virus B vaccine candidate.
Which demonstrated tolerability and proof of mechanism by way of Phase one data reported earlier this year.
We believe we are well on our way to Catalyzing, a fundamental paradigm shift in the approach to managing serious life, threatening and debilitating or to immunity.
This will become a reality with the potential approval of <unk> for the risk <unk> indication.
And thereafter, we look forward to pursuing tap lithium <unk> full potential by way of label expansion, including our plans to study its use in patients under eight years of age.
As well as the re dosing of patients to potentially extend the three year median delay in onset of insulin dependent disease in at risk individuals.
We are also excited about the prospect of using <unk> as an adjunct to beta or stem cell transplantation.
Beta cell transplantation targeting a prevalence of one 8 million patients with established end stage disease in the United States alone.
It remains challenged by having to depend upon chronic immunosuppression to protect transplanted cells from the auto reactive T cell attack.
Destroyed Ah patients original pancreatic beta cells.
With that operator, we would like to open up the call for any questions.
Thank you at this time, we will begin the question and answer session.
Ask a question you May press Star then one on your Touchtone phone.
Speakerphone, please pick up your handset before pressing the keys.
Sorry. Your question. Please press Star then two.
At this time, we will pause momentarily to assemble the roster.
And the first question comes from Justin Kim with Oppenheimer and company.
Hi, good morning, and thanks for the update and taking my question.
Just wanted to ask a quick question first on the <unk>.
The note about expected FTA requests on proposed labeling and post marketing requirements.
One month prior to the extended due date just wondering if this is something that we can expect on an update by that point.
Whether it's really the Purdue for that.
Focused catalyst.
Good morning, Justin. Thank you for the question. So we would expect to provide an update on our regulatory.
Status.
Time of the Q3.
Results.
Okay, Okay got it.
And perhaps maybe on a related note with the strengthened balance sheet. I know you gave some color on in terms of you know.
Terry six spend but just wondered if theres anything thats now I'm dated with maybe a healthier balance sheet any sort of activities that the company is excited to distribute engaging.
Over the coming quarters.
We remain in a dated manner.
In the.
The same way as we did prior to the expansion.
Coming up to the year approval in.
Reduction in regulatory risk.
Okay.
And maybe just a final question on for commercialization.
They're really extensive presentations Jason.
Earlier.
Just wondered if you could provide some thoughts on how you think about the timing of a hybrid distribution model coming online.
Just sort of things that we should be thinking about as we think about sort of modeling revenues.
Thanks, Mike.
Getting J codes establish et cetera.
Thanks, Jason.
Yeah, absolutely. Thanks for the question, Justin So with respect to J codes.
As long as we meet our January January submission deadline.
Well, we'll have a permanent J code effective as of the beginning of July so as long as we hit that January deadline for the submission of the application for their permanent code.
Be notified of the permanent code at the beginning of the second quarter and that code will go live at the beginning of the third quarter. So we'll be working essentially with a miscellaneous J code from the time of approval until essentially the beginning of July of 2023.
With respect to the hybrid model of distribution that model will be ready to go essentially day one.
But with that being said I would anticipate that we will see especially in the early days more of the infusion than not happening under observation in an infusion center and then as people get familiarity using the pleasant app as they develop comfort.
We would envision that they would potentially start transitioning patients to home infusion just given the reaction that we heard in qualitative market research with health care providers and patients and caregivers alike on what what the notion of home infusion can mean to them with respect to eliminate removing as many barriers as possible with respect to that that 14 consecutive day infusion.
Great. Thanks, so much and congrats on the progress.
Thank you Justin.
Thank you and the next question comes from Ram <unk> with H C. Wainwright.
Yeah.
Thanks, very much for taking my questions. Firstly I was wondering if you could maybe comment on if there have been any challenges to commercial readiness associated with the extension of Paducah date or if from your perspective effectively get any.
Difference with regard to establishing the organization and recruiting the people that have onboard.
Yes. Thanks for the question, Rob So from our perspective, we were as close to readiness as we could possibly be when we received word of the three months delay. So while we have slowed down a few items.
Consistent with the three months delay that will be re initiated and in due course.
With respect to the new readiness date around November 17th we were really well on track toward readiness. So from our perspective, we are using these additional three months to continue to drive disease awareness messaging to drive screening messaging to engage with key opinion leaders and key stakeholder groups like advocacy organizations.
And just crossed the ice in doubt that he is like I mentioned during the prepared remarks with respect to.
Readiness, and the new timelines and making sure that.
That we're using the time effectively to continue to be ready, but I felt really confident going into the August 17th date I feel equally as confident going into November 17th with the additional three months.
Thank you that's very helpful. And then just a quick follow on with respect to how much they are.
Development work that is being done in the type one diabetes space can you comment on and maybe this is a question mostly for Ashley.
On how this is likely to long run impacts away to prison Abbott utilize deploy within the <unk> space. For example, if we consider the <unk>.
That semi has been.
Clearly the may have less relevant for the initial at risk population.
Possibly more.
The utilization of <unk>, Paul, but just wanted to get your thoughts on that.
Yes, thanks very much Ram.
Scientists the prospect initially.
Post approval.
For label expansion.
Mono therapy to make sure that we.
<unk> optimize the potential we certainly want to examine the.
Under eight age group.
Was not studied in the <unk> pivotal trial.
We obviously want to look at re dosing and may be francisco's who's on the line can speak about.
The.
The re dosing.
Opportunity, but then to your point we wanted to.
Look outside of at risk, we've got newly diagnosed with the protect study.
Which is now fully enrolled.
We're expecting top line results.
In the second half of next year.
And then to examine.
In both directions.
Going.
Earlier looking at whether we can intercept this disease in stage one when there's two auto antibodies and no disgrace EMEA, yet, but then to your point established end stage disease in patients who would otherwise have a lifetime.
Of of insulin dependence can we support the $1 8 million patients in the United States.
The prospect of.
Transplantation therapies, where we would be used in combination at the moment.
The near term.
Our vision for those transplant patient therapies.
It would be.
To administer the transplants with chronic immunosuppression.
But trading a lifetime of in some independents for a lifetime of chronic immunosuppression, especially in young children and adults.
There's lots of.
Type one diabetes.
Then.
That's not necessarily a clear.
Wind for the transplantation therapy, but if we could reset reboot the immune system with TERP lithium mob.
As those.
B cells are transplanted.
Now.
<unk> them to pay can be maintained.
And.
Preserved that's a different that's a different outlook, obviously I realize some of the transplantation therapies are looking at gene editing and other.
But more advanced technologies.
<unk>.
Avoid immunogenicity and allow the transplants too.
Be independent themselves, but I think that's some way off Francisco do you want to talk about re dosing and maybe also.
Our vision for how <unk> could.
Be used outside of.
Type one diabetes and.
Also in combination with Tolerogenic.
Technologies and other combinations.
Yes, good morning, Ron Thanks for the question.
With regards to re dosing we have already made those over 400 newly diagnosed patients successfully so we know it can be done safely.
<unk> enhances the efficacy.
So the next step is to.
The clinical study post approval in at risk patients.
And we believe we can use some of the Biomarkers, we have such as the exhausted T cell levels to help guide the optimal timing for re dosing, we will test that hypothesis.
Mentally.
Potentially by adrenal dosing to three four times over childhood, you could present clinical <unk> indefinitely and get people superior team when the risk becomes much lower and above H.
With regards to non type one diabetes indications.
We have.
A lot of scientific knowledge that supports the use of the broken map in T cell driven diseases.
For example, celiac disease, but also.
Friday's multiple sclerosis, crohn's disease et cetera.
And we intend to study some of these indications post approval as well we already have proof of concept in psoriatic arthritis.
In addition to transplantation as I mentioned earlier.
Thank you.
Thank you Ram.
Thank you and the next question comes from <unk> <unk> with Cantor.
Hi, good morning, and thanks for taking my questions.
Lastly, just to clarify.
The antidrug antibody was already part of the original PK model and the FDA asked for some update so first question what exactly is this a bit of data.
From the ongoing phase III product trial.
Secondly, I think I heard this but given its importance. If you can confirm logging on whether after the inclusion of the updated <unk>.
Data in the PK model.
The PK parameters were still about 80% for the lower limit of 90% confidence centrally. Thank you.
Thanks, very much so it was less the case of additional data as additional modeling taking into account.
<unk>.
The anti drug antibody.
Data that we have making sure that it was all included in the model and updating that model to include that data Francisco would you like to add some more color to that.
Yes, so as you know the protect clinical trial is ongoing.
And we have generated some additional.
Data real time.
So the FDA asked US to include these additional data in the model, where we already have 88 data and then deliver them.
The model for the adjusted dosing regimen that we're proposing in the recent meeting BLA.
So we did exactly what they asked us to do.
Additionally, the data did not affect the outcome of that adjusted dosing regimen is the same and we resubmitted our <unk> responded to the FDA.
The answer to your question.
Yeah.
Yeah.
Okay.
Okay.
Okay. Thank you. Thank you thank.
Thank you and the next question comes from Thomas Smith SVP Securities.
Hey, guys. Good morning, Thanks for taking the questions just.
Wanted to follow up there on the last one and maybe actually if you could just talk a little bit about the fda's overall level of comfort in I guess your overall level of alignment in terms of the.
The PK models proposed dosing I know you guys developed the model consistently together, but it sounds like you are incorporating some of the new.
New data from the protect study so I guess, just if you can speak a little bit in terms of your overall level of comfort that you guys are on the same page with the PK model proposed dosing.
Yes, thanks very much.
Obviously.
I'm not in a position to talk about the Fda's comfort, but we certainly are responding to all of their routine.
Information requests.
In a timely manner.
And as I mentioned.
The.
Information request in mid June with really updating our mobile.
With additional data that was.
It had already been collected in making sure that that model.
Was replete with consideration of the antidrug antibody <unk>.
Information, we have available to us.
The agency.
Been extremely collaborative.
And.
Supportive.
And we have a very good.
Positive favorable interaction sponsor regulator interaction.
As far as my experience in the industry is concerned it is.
Very good.
Okay. Yeah I appreciate that color and then just I guess along those lines I mean, you do have.
Breakthrough therapy designation can you just talk a little bit about how frequently you're in contact with the agency at this point during their review how dynamic is the dialogue and <unk>.
Similarly, it sounds like the FDA is really working with you too.
To try to get the the application over the finish line here, but maybe if you could just provide some color in terms of.
Our breakthrough therapy designation is helping you engage with the agency.
Yes. Thank you I mean, we really don't.
Comment on our Reg.
Regular routine interactions with the agency, we obviously report.
Material nonpublic information.
When it becomes available.
But the whole breakthrough therapy designation has had.
A very significant impact.
On the development of <unk> for the.
The at risk indication as.
Many of you will recall, we acquired <unk> for Macrogenics.
The initial intent to do the newly diagnosed indication.
And repeat a phase III clinical trial.
When.
The at risk data.
Through the NIH trial net.
<unk> became available.
We.
<unk> filed for breakthrough therapy designation.
Receive path.
<unk> received guidance from the agency as to how to.
Package and analyze.
This data.
<unk>.
Breakthrough therapy designation requirements.
Potentially compelling efficacy data against.
A disease with significant unmet need.
That led to a rolling.
L a submission during.
The original BLA submission.
Which was.
Extremely useful and helpful. Culminating in the last module, which is the CMC module being filed in.
In November of last year, it led to a six month.
Review once accepted by the agency in January of last year.
It led to.
An advisory Committee.
And a subsequent TRL, which clearly showed.
That the safety efficacy.
Risk benefit equate.
Equation had been met because the CRM really didn't.
Raise any deficiencies with regards to safety or efficacy.
From a clinical assessment point of view, we were left with this challenge of the agency wanting to be reassured that the material that had been historically used in the pan.
<unk> 10 study, which was manufactured 12 years ago now.
With that material would be comparable with the material, we intended to to launch with <unk>.
So thats, what we have been working with the agency.
To address that.
That need throughout the last two.
<unk> months and they've been very supportive with regards to guidance on how to build a population PK model in order for us to unblinded data that was collected from.
Actual patients on therapeutic dosing using the two materials in our protect study.
Having a model that there could be a very significant difference in PK from the.
Fractional low dose.
That was done before the Advisory Committee.
Meetings were held last year in in healthy patients.
And of course.
The recent history.
That data.
From modeling.
From the protect study at therapeutic dosing brought the point estimates.
While within the PK comparability range.
But the lower confidence interval.
We will keep.
PK parameters.
Just below that.
The PD biomarkers, indicating the impact of the two materials.
It was essentially indistinguishable.
But the agency advised us.
Two.
Hum.
Make.
The proposal regarding a dosing adjustment.
To ensure that the PK exposure was was matched and that.
That would then bring.
The lower confidence interval within within the range and that's what we've done.
Got it got it Super helpful. Thanks Ashley.
One last question just can you just remind.
Mind us of where you are in terms of manufacturing commercial supply, but supposing that it sounds like youre going to be.
Pretty much ready to go pending approval in November , but just remind us how much commercial inventory youre building up at this point to supply the market.
Yes. Thank you very much yes, we are.
Ready to go.
In terms of.
Material.
To supply.
The supply chain, Jason do you want to speak to.
Any details beyond that.
Yes, I would just say Tom we have we have.
We have adequate supply to launch.
That's essentially.
Ready to go that assume as soon as we get a final blessing on packaging, we can start to package. The products. So I feel confident that we have adequate supply going into a launch later this year.
Okay.
Got it alright, thanks, guys I appreciate you taking the questions.
Thank you Tom.
Thank you.
Next question comes from David Wang with SMIC.
Hey, guys. Thanks for taking the questions. So first I just wanted to ask about I think something that we discuss during the <unk>.
Investor day on commercialization and in terms of the 14 day infuse.
Infusion regimen.
There are I think some centers that don't have weekend availability.
Which would obviously be hurdle and so just wondering if you guys had kind of looked into that any more or I had approach centers and found that they are amenable to providing the needed availability and potentially adjusting their hours.
Jason.
Yes, thanks for the question David So.
We're hearing.
It's a good point with respect to weekend hours and we've seen I would say an evolution with respect to the feedback we're hearing about this over the course of the last couple of years.
What I would say is that Dr. Kimber Simmons with the Kols, who participated in our commercial investor event as you know.
<unk> discussed the preparations that she and other centers in Colorado are taking specifically she mentioned how Barbara Davis is preparing for a potential launch in that they already have weekend hours at their center, which isn't isn't necessarily surprising giving it given an academic center of excellence, but you also noted that our Colorado Children's hospital, where they have been in.
Conversations and.
Just just speaking with them about their potential setup that they hadn't had weekend hours, but that they are actively planning for ways that they can staff. The infusion center over those weekend days. So I think what we're seeing is an evolution towards more and more centers and more and more infusion centers thinking about ways that they were.
We'll intend to staff, many of whom have already put in place ways that they'll have weekend hours.
Obviously, we can't say universally that that's the case, but it's specifically for that reason David that we designed the distribution model. The way that we did so that we would have the potential shift a clinician <unk> patients or their caregiver.
Want to transition to home infusion for that first weekend of care that option is available to them.
But with that being said.
We would intend to work our patient services team with health care providers and infusion centers in their local area as best they can on a on a case by case basis based on where patients live, but it's nice to see and refreshing to see.
The way that they've evolved over the last couple of years and just how prospectively theyre thinking about staffing those weekend hours I would say, we're hearing more often than not that.
That they have they're either generating plans or are they already have plans in place, but I can't paint all infusion centers with the same brush I would say that from a trend perspective, that's what we're hearing them.
I see okay, great. Thank you that's really helpful. And then I just had one question on.
Going back to re dosing.
I understand that once we hopefully get an approval.
Some work to be done there and flushing out the re dosing strategy, perhaps more formally but do you expect that there will be any type of language in the drug label itself for the initial approval that refers to re dosing or has this come up with the FDA where they.
They want to say anything necessarily about re dosing.
Upon approval.
We've not had conversations with the agency to this point on re dosing.
It's.
It's not something that we have discussed regarding labeling but.
I would.
I would suspect.
The labeling.
We will indicate the experience was.
Had with the <unk> study, which was a single dose and it will be up to the company to then.
<unk>.
Data for the agency to to add to the label in regards to whether re dosing.
Makes sense.
And then so how to assess when to do it and then certainly to provide.
That data.
The label is expanded to payers, who clearly.
Clearly one too.
Understand that a second doses.
Pep lithium and leads to a better outcome.
Okay, great. Thanks, a lot.
Thank you David.
Thank you and this concludes our question and answer session I would like to return the call to Ashley for any closing comments.
Well, thank you Keith and thank you all again for your time and attention. This morning, we very much look forward to keeping you updated on our progress throughout the remainder of this year and we sincerely hope that you enjoy the rest of your summer with your families. Thank you.
Thank you. The conference has now concluded. Thank you for center today's presentation. You may now disconnect your lines.