RE:RE:RE:RE:Soon catalysts of THTX? If for no other reason than starting the trial and getting approval will allow management to talk more confidently as a true Phase 3 player, it's important. No matter how the program is viewed, once they start the trial, discuss the plans and perhaps show some interim measurements, they will eventually have to be viewed as a serious competitor who only needs to show efficacy, not safety/dosage issues. The huge market is still there, there's only 1 or 2 treatments that could gain approval over the next 2 years, so they will still be early and differentiated in many ways (HIV, upstream, "natural" stimultus for liver health, etc..). Let's not forget the KOL talks about two trends that play in favor -- the heterogenity of the disease and the likely need for combinations in the future.
We've never heard of a delay yet. But I do know from following various other trials that to put together a global (possibly) trial with 30-40 sites, all the testing and signups, etc... can't be easy. If they are adding in a lot of the new information to help enroll the "right" kind of NASH patients and also do the interesting secondary data collections, etc.. just planning it is an enourmous task for them. The cancer trial is in many ways a lot easier not just because of size, but because it's more routine and standard at this point. MD Anderson knows exactly what to do and it will be a lot quicker. I think as we learn more about the NASH trial details some excitement around it may start to build and they can explain it all a lot better and more confidently.
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.