RE:RE:RE:RE:RE:RE:RE:RE:Annual meeting That's true for all NASH players but it does not stop most of them being clear on their plans, Akero managed to clearly signal their plan for an unusual 2/3 trial even before the regulators gave their final opinion. I like the idea that it's the difference between the ema and fda that's holding things up but it much more specific to details of the thtx's program than to the general approach of the two regulators.
jeffm34 wrote: The delay in trial design is most likely related to the differences in approval criteria between the FDA and EMA. TH is trying to come up with a trial design that will satisfy the FDA and EMA
"lack of harmony between the FDA and the EMA complicates the development pathway for NASH:50 While the FDA only requires the achievement of one NASH endpoint (improvement of ≥1 stage in fibrosis with no worsening of NASH or improvement in NASH resolution with no worsening of fibrosis)51, the EMA’s draft guidance requires efficacy in both these endpoints.52 This will likely limit or delay approvals of first movers in the major European markets."
qwerty22 wrote: "QWERTY says the FDA will not reverse its decision on the phase III trial but I have to think that fear of a reversal might be playing a role in this situation."
I would never say "will not" when it comes to regulators but...... From what we understand they aren't presenting new data in these continuing discussions so I don't understand how the FDA can reverse their clinical decision. On what basis would they do that?
SPCEO1 wrote: Unless we are missing something the analysts can see, there is just no excuse for the company not being able to convince the market that NASH is real and therefore the stock deserves to be valued like all the other late stage NASH stocks.
I mean, it really should not be hard to convince investors if you have been able to convince the FDA.
QWERTY says the FDA will not reverse its decision on the phase III trial but I have to think that fear of a reversal might be playing a role in this situation. The Biden FDA has already shown itself to be less friendly to companies than the Trump FDA. Still, the bigger problem is likely the fact that most investors are unaware of the situation. If insitutional investors are not listening to the TH messengers on this, than maybe Paul needs to get more aggressive himself in speaking to those investors.
scarlet1967 wrote: Many have said it before the valuation is the projection of the market's perception so the market didn't ascribe any value to phase 3 NASH even with FDA's go a head meaning market doesn't believe in their program at all despite the fact that the agency does.
Now we know their approach is different which is the possible reason why the market doesn't understand it, they managed to convince the agency now they have to convince the market and that's where it all falls apart. The market equaled difference as no value so the company has to change that perception...
Bucknelly21 wrote: I'm curious does getting the fda letter to proceed for phase 3 and the market not even sniffing at it the same kind of irrational market behavior you are referring too?