RE:Some Additional Random ThoughtsThe problem with NASH is not the science behind tesamorelin in this application. It would have a fair shot at success. The problem is that the trial requiered by the FDA is enormous for a small company like Thera who gambled two years ago they would get better conditions from FDA for this trial and decided not to do a phase II because of that. So it's a strange story. The believed so much in it two years ago that they decided not to start a straigth phase II trial in general NASH to back the prospect of a phase III trial. But without real phase II data in the general population, FDA ended up requiring an enormous amount of patients, so much that a small company like Thera cannot afford it, and without a proper phase II in general NASH with convincing results, partners are not willing to jump in. Add to that the fact that two years ago the F8 formulation was not ready, and that a pen injector is still not ready, and you have the situation they are in.
They cannot go in it by themselves, and no partner is willing to jump in. Two years ago NASH was the main program of the company and oncology was an inexpensive backup plan. If they are willing to enroll 70 patients in phase Ib, I guess it's because they believe oncology is the future for them, and they don't have the financial ressources to run two clinical programs at the same time, so it makes NASH expendable. If they have spectacular results in some cancer types in phase Ib, and that the SP skyrockets, then maybe they will bring the NASH program back to life, but I am not sure it would be a good idea.
SPCEO1 wrote: Should TH just shut Europe down? They are evidently not going to get the price they require in most places there and the optimistic projections they made about what was possible there are almost certainly going to come up way short. The competition is only getting tougher - I am just not seeing it being a meaningful profit contributor and the risk is it remains an unnecessary drag on cash flow. Now, if I recall correctly, TH paid Taimed $5 million last November as part of the European rights deal so they must have looked. closely at it then and decided to press on. But it would be nice if they would explain to shareholders how it is this is a good thing to keep spending money on. Maybe there is a good reason but I am not seeing it.
I have only seen a research report so far, from NBF. This analyst hates TH and it is revealed in how he put his report together. He leads off with the weak Trogarzo sales, then turns to Egrifta and downplays the good results there by noting theose sales were less than the Q4 Egrifta sales while never making note of the seasonality involved and finally turns to cancer where he spent all of two sentences explaining to his clients almost nothing of relevance about it. Naturally, he also noted that TH's Q1 sales were less than his oddly high sales estimate, something that remarkably seems to occur nearly every quarter. One almost is led to think this is intentional so that he can say TH missed his estimates. But TH is also to blame. I think there were 2 or 3 days left in the first quarter when they established sales guidance for the full year when reporting Q4 results. They clearly knew what Q1 sales would be and they should know by now the incompetance of the analysts covering the stock in accurately predicting their sales (asssuming they are even trying to accurately predict sales). Whatever the analysts' motivations for their amazingly consistent ability to be too high in their sales predictions, despite a massive amount of evidence that they should be more conservative, TH could have easily made sure that no analyst would be off the mark by giving guidance on the quarterly sales too. They would have been able to avoid the headlines that repeat every single quarter that TH missed analysts sales estimates, which is a bad look for the stock. I mean, this is so easy to fix and TH just punts on it? This is just one of the reasons the IR effort at TH has been so bad for so long. They cannot even fix the easy to fix stuff!
TH's water problem with NASH may be a easy way for them to ease into just completely shutting that down altogether. They performed heroic deeds in getting it to the point of being possible, and it may yet turn out to be a very big deal, but by the time they get the water supply back, cancer may be the main thing and spending precious shareholder resources on NASH may not look as sensible given they may have a much better cancer bet staring them in the face at that point. Also, in the financial statements notes, TH indicated there would be some write-offs associated with the temporary cessation of the NASH program. I asked a question about it but they chose not to answer that one. I guess we will find out in the Q2 report in early July. With the write-offs already taken in Q2 related to NASH, could they just move on altogether from NASH as their case is hardly a strong one as evidenced by the lack of partnership interest and the TH's boards own reluctance to fund it to get it going. If it was a no brainer, we would already be in the midst of the pahse III trial. Qwerty was right about this - it is not a real thing until the trial was started. But congrats to TH management for making it interesting for a while. And maybe they will yet complete the miracle they performed with NASH but my best guess is that it drifts off into the sunset slowly.