RE:RE:RE:RE:RE:RE:RE:Annual meeting I don't think they will reverse it but I suggested a fear of reversal is something that may be keeping the market from giving the stock a proper value for that program. And the basis for reversal may be as simple as there is a new sheriff in town at the FDA and he does not like anything the old sheriff did, so he plans to unwind as much of that as he can. Several companies have already been negatively impacted by this type of thing and that is one reason why the XBI index has been crushed since mid February. My concern is that someone above at the FDA says, "no, that is too weird - make TH do a phase II in NASH first"'. I don't think that will happen but the change of administration and the recent problems sime companies have had mean I will be happy to hear that the phase III NASH trial is finalized in every respect.
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?