RE:RE:RE:RE:Soon catalysts of THTX?FDA and EMA agreeing would send a strong signal. That being said, I think you answer part of the question with your own digression into some doubts. Personally. even thoufg I think they will proceed with the trial, I am not 100% sure about that. From the outside, they look very careful and said they want to learn from other companies mistakes. I think they believe in tesamorelin in NASH, but they fear the regulatory landscape of this indication and some technical aspects of the data collection. They mentionned in one of the call or presentation odd stuff that had hapenned in the placebo arm of a NASH trial by another company. Add to that the 18 months of treatment instead of 12 months. I think that even somebody following the company closely cannot be 100% sure they will do that phase III. That's why I think the SP will rise if they can clarify the protocol, and start the trial, with the backing of at least the FDA .
SPCEO1 wrote: The company has already clearly signalled that the outstanding questions from the FDA are not an issue that will derail the trial. My best guess is they company tried to get the FDA to agree to a cheaper trial and the FDA was not buying it. So, I am not sure that being formally resolved will mean much for those few of us paying close attention to the stock, but perhaps the average investor has a higher bar that only TH has to cross before they are willing to value TH's stock more fairly relative to other NASH stocks.
Do you have any thoughts on how critical getting the EMA to buy into what TH wants to do on the NASH trial is? My sense is that it is ideal to get them on board but hardly necessary. But I wonder if my sense is wrong on that.
Also, I have been wondering also if the board, who knows more about the relative merits of TH's NASH opportunity than we do, has delayed the final call on this trial until September (assuming they don't further delay it) because of a weakness we might not be aware of and a concern that spending the huge sum of money required for a phase III NASH trial might be unwise. That might explain the rushed offering on the back of the "study may proceed" letter from the FDA and the delay until December as well as the greater focus TH has given to cancer lately in their presentations. I was happy to hear Paul give alot of attention to NASH in his latest presentation but am still left wondering what is really going on with NASH. Perhaps one of the reasons the company will not point out the difference in valuations between TH and other NASH stocks is because they have some reason we are not aware of to question its prospects? If they really beleieved fully, you think they would be screaming alot about how the market is not giving TH's s tock price the appropriate credit.
Perhaps the market senses such a reluctance and that is the reason for the valuation gap? As you know, I don't think only TH should be held to some criteria for getting credit for its NASH program that other NASH companies are oddly not held to.
jfm1330 wrote: News of agreement with FDA, and hopefully EMA, on the trial protocol, and news of the actual start of the trial. The stock price will not skyrocket on those news, but it should rise.
SPCEO1 wrote: I am not sure what finally will convince the market the NASH opportunity is real but when that happens, the stock should move considerably higher.