Theratechnologies Inc T.TH

Mischaracterization of the FDA process

[Spartrap]

I've read many times on this board, that we have to wait for the FDA decision about the filing for Phase III, that this may extend past a month. I think this is a mischaracterization of the FDA process. The filing we are talking about, unless I'm mistaken - and I'd love to be corrected then, is a Commercial Investigational IND, which includes many parts, among which a protocol for trial. The FDA doesn't have to explicitly validate it for it to take effect: it's automatically valid 30 days after filing if the FDA doesn't say a thing. So essentially, it's opt-out, not opt-in, and conversely, the FDA *may optionally* give it the get go before the end of the 30 days. See: https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview Quote: "An IND application may go into effect: -30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or -on earlier notification by FDA that the clinical investigations in the IND may begin. Once an IND application is in effect, a drug manufacturer may ship the investigational new drug to the investigator(s) named in the application."

[SPCEO1]

While it is true a company can start a trial without the official approval from the FDA, uner the circumstances of TH's NASH phase III, I suspect the management and board of directors of TH would like to know the FDA is on board with their approach before spending $70 million or more to do this particular trial. I imagine they would want some indication that this trial would be viewed as a

[Wino115]

I don't know all the various differences, but I think they are filing this as a supplemental (SNDA) since the drugs already approved and in use for a different indication. I guess it's technically not a "new drug".   Not sure if that changes your time line though. 

[Spartrap]

SNDA is what you'd file for once the pivotal study is done. But initiating a study for a new indication even for an old drug is still governed by the standard IND filing process, I believe.

[Spartrap]

I'm sure they want the FDA to be in agreement, but this is the role of pre-IND consultation programs, it doesn't affect the timing once the filing is done. I just mean to say: there is no big "decision" or "approval", just a remote possibility of the FDA walking against it's own guidance by answering by a Clinical Hold before thirty days.

[SPCEO1]

From how you describe it, the fact that they are filing a protocol means the the FDA is already basically in agreement because of the pre-IND negotiations. Which is why the company expresses confidence and the board of directors has signed off on this project. But there must be some uncertainty still or the company would likely have communicated that it is a done deal already - right? 

[Spartrap]

Well the uncertainty is: we have no news of the filing itself, and the CEO was spotted saying the dreaded "in the coming weeks" again just a week ago or so.. So polishing/harmonizing that protocol is for sure taking very long. But I don't see much uncertainty in it. It *is* going to be a P3 since they announced it, and it's almost as good as a done deal the moment we learn it'

[qwerty22]

So you're suggestion here is they've had all the pre-IND meetings with the FDA, got to a consensus position between the two sides and now all that's left is the technical issue of filing the IND? The Ph3 announcement is de facto a declaration of this consensus position? My question is why haven't they clearly communicated this? As an example here is Akero's statement

[qwerty22]

Btw I'm not suggesting you're wrong about the process, it does make sense what you are saying, I just don't understand how that chimes with what they've communicated.

[Wino115]

I guess another question would be, what could the consultation have been to have NOT issued something like what Akero did? If what Spartrap says is the typical route for regulatory consultation and pre-trial submissions, they would be further along than Akero in the process I think.  It could just be their ingrained conservatism with anything to do around regulators.  I was sort of

[Spartrap]

In my opinion, what it signals is just the simplest, as Occam's razor posits: that agreement on the principle of a Phase III was reached by all involved parties (including EMA), hence the clear communication about filing for Phase III in Q4, but disagreement remained on technicalities (and that's hardly surprising), so they did not have any specific pledge of acceptability of the then

[ggg088]

I am not a technical person in the pharmacy industry, but I guess that insiders bought more shares can prove management would be confident to get approval of phase III.

[longterm56]

Oh NO!!!!!  This is really bad news!!!! We've been postulating that it is the "FDA Approval" that would finally move the stock and "get it treated as a Phase 3 NASH stock". Now it sounds like the "30-day" period for FDA to complain will just be a big yawn with no significant announcement. So does that mean the market has already priced in the Phase III NASH

[realitycheck4u]

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[Spartrap]

That's complete nonsense. I just explained the FDA has at most 30 days after filing to oppose the trial (and might even greenlight it ahead of that). It means the trial will move forward sooner that was generally expected here and possibly become a reality before EOY. There will be many "catalysts" along this way: trial page opening on clinicaltrials.gov, recruitment starting

[scarlet1967]

I am pretty sure an approved NASH phase 3 or any late stage trial for that matter hasn't been priced in by the market and I am pretty sure the company will announce the formal final submission as they did for Trogarzo both in the US and Europe, I just hope they don't opt for an dilution prior to agencies verdicts which as mentioned earlier will only shows all the confidence company put on

[SPCEO1]

What is clear to me is there is a very good chance the Phase III will go forward. But it is not 100%, so there remains some degree of uncertainty. Since it is an all or nothing wager, analysts have been unwilling to factor any value into their price targets until the FDA/EMA formally indicate they are on board with it. When/if that changes, the analysts should react to that uncertainty being