RE:RE:RE:RE:Soon catalysts of THTX? You still get fresh articles about the breath of the programs in NASH, the multitude of different MOAs, growth hormone never has a place on those lists. I just don't think, broadly speaking, there is any real acknowledgement of thtx's program in the market. In effect we are still waiting for the market to realize there is Ph3 program springing from nowhere. Either that or the market has weighed this up and doesn't like what it sees, ai don't like that option.
I don't think the fda hand out "study may proceed" letters provisionally. If they have one then the fda is already on board. I think this is more to do with the company doing the due diligence on the program to ensure they take the best path from a risk perspective and that still involves further interactions with the fda. We learnt that the fda has made some new comments around the safety aspects of NASH drug programs at the start of the year so maybe that is part of it, maybe part of it is still trying to understand how their "odd" dataset fits.
WRT to the EMA I just don't understand how to gauge that. How far are the EMA from the FDA? Is it necessary to resolve all the issues with the EMA before starting an FDA orientated trial? Can the EMA be brought on board thru a parallel process that runs alongside the Ph3? I can understand the company wanting to 'derisk' the situation with the EMA before the Ph3 begins (if risk exists) but it may not be essential.
I think the way I think about it generally is
1) There is no hurdle to get over with the FDA, there is just the need to generate an optimal protocol.
2) There are potentially issues to resolve with the EMA. Best case scenario is they are resolved before the start of Ph3 so take the time to do that. But if they aren't fully resolved then that doesn't stop a Ph3 from proceeding. There still may be other ways to bring the EMA on board.
That would explain why they have a letter may proceed but aren't immediately proceeding and at the same time are not faltering in saying they have a Ph3 on the horizon.
But all this is guessing on something that isn't in clear to me.
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.