RE:RE:Question for those complaining aboutFor me, I am not as concerned about where they satnd on their NASH program as they have been told to go ahead with the phase III by the FDA and they have committed to doing so. Whether they get harmonized with the EMA or not is not as critical to me as I have to believe if they have good results from a US based test, the EMA would not totally ignore that. So, NASH is a real thing and investors should give them some credit for it in my view.
Now, I have also said that the delay until late this quarter to start the phase III NASH trial may have something to do with the cancer trial. If they have positive results from cancer before they start that trial, it may effect the desire to spend a fortune in NASH for results that are by no means assured of being positive. Maybe they have a partnership opportunity in NASH (I suspect not though) that they can take if cancer is looking good. The long lead time between the FDA giving the trial a thumbs up and the actual start of the trial tells me there is a chance there may be more than just EMA harmonization issues slowing things down.
So, while I think they could be marketing NASH better to get at least some credit from investors for it, the situation is still a bit murky because of the ultra slow advance to phase III despite the clear go ahead from the FDA.
One thing is for sure, any remaining uncertainty about the phase III NASH trial cannot go on much longer if they intend to stick with the current schedule for the trial's start. Maybe Longterm's concern that the start will be pushed back further is legitimate. And if the TH board does want more cancer data before starting to write big checks for the phase III NASH trial, they mamy not have all they need before the end of Q3.
Does anyone think it is even possible for TH, after discovering they have some very important results in cancer, that they would just drop NASH altogether and say they are focusing on cancer alone? I doubt this is likely but it is also not inconcievable. NASH is costly, will take a long time to get results, the program is built on less than ideal data and competitors have struggled to meet the FDA's standard for a successful trial. If I were the TH board, I would try to partner it at a minimum and if that failed, I might just jettison it altogether if the cancer data was fantastic.
Also, if they are gogin to really get started at the end of Q3, I have to believe they would have had to do a lot of work on preparing for the trial by now and it is not clear to me that such work has been done.
qwerty22 wrote: We've had 2 1/2 years of NASH now. We've got a lot of hindsight to work with. It's been mostly silence from the company with the occasional bold statement. You think the silence is a failure to promote and you want that fixed. I think the silence is more indicative of where that program actually is. You said it in an earlier post, some of the bolder statements were probably made to support a financing. My view is from the NASH KOL event onwards they had an eye on financing, that's when most of those statements came out. Before, silence, after the financing, silence. If we go back 15 months the only thing standing in the way was "harmonization". Do we hear about that anymore? Did they report successful harmonization? Nope, they put an IND in with one regulator and not the other. My best guess, they didn't want to hear (and be obliged to report) what the EMA would say. The indications are harmonization failed. Why?
It just doesn't feel right that this 'end-of-Ph2' process should take so long without that extra time being explained by issues. You know my problem with all this can be summed up in one word - biopsy.
I'm super uncomfortable with the next statement. I think as a biotech investor you are always looking for the moment when a company can make a leap forward (PoC, move to registrational phase etc). Right now I feel most comfortable if thtx took a step backward. To me the dataset fits a very promising Ph2b program, I think the investment community would look at it with fresh eyes from that perspective. As you said the NASH sector has moved to a new (less attractive) place, I think chasing Ph3 in that environment looks even more out of line with investor expectation in NASH. But as I say it feels so wrong to want them to take a step backwards I must have something wrong here.
All this is a roundabout way to say I think their biggest problem is not marketing, it's clarifying where NASH actually is. Once they do that then they can market it. I think they have probably been trying to sell the idea, via the traditional routes, and the collective response was "No thanks". I'm worried if they finally offer an FDA Ph3 protocol they'll get the same response. If they come up with something more creative then maybe people will look at it with a fresh perspective.
(If you are an author you can't go to readers and sell them half a novel with the promise the second half will be finished soon. I think you are asking them to market half a novel. I think they've probably been trying to do that for the last two years and failing. I share your frustration but if they had pumped this to retail investors from the start probably all we would have is more frustrated investor waiting for a NASH protocol)
SPCEO1 wrote: those of us who complain about the substandard efforts, or in some cases just the substandard results, of TH regarding marketing the stock to investors.
Since the complainers about the complainers seem to come from the scientific arena, I thought this question might help you understand where we are coming from on the business/investing side of the equation.
What would you think if TH produced great scientific results but refused to publish them or speak at conferences about them? Or what if they presented at conferences and published their work in scientific journals but their presentations were much weaker than what you had become accustomed to from others using the same venues? I imagine you would think that to be foolish and would be quite frustrated by the company missing out on getting the notoriety their work deserved.
For us on the investment side of the equation, it seems equally foolish to not fully inform the various types of investors who are constantly on the lookout for stocks with intriguing and potentially very profitable opportunities. OR to try to do so but continuously fail to pull it off when so many other companies seem to be having very little difficulty doing the same thing with worse fundamentals and business outlooks.
Does that help explain our frustration??