jfm1330 wrote: Today's call focused on a four years plan to official approval of a new formulation of Egrifta for HIV NASH. As always it was non promotional, based only on facts and realistic expectations. This should be good news for long term investors, but the problem with Thera is that most of their investors are in since a very long time and a bit tired of waiting for the real break out of the SP.
On the promotional scale, TH is normally on the low end of it unless a stock offering is imminent or ongoing. While I generally appreciate that approach, I think they can take their promotional efforts up a few notches in a non-offering mode without sullying anyone's sensibilities too much. The stock should be up significantly today and perhaps if the compoany had just released the presentation and not even spoke about it, the stock might be. It seems that frustration with the underselling of the HIV NASH opportunity is what set off the selling. The data in the presentation was sufficient to elicit a postive response inthe stock.
The disappointment today was for those thinking that some kind of label expansion was possible without a new phase III study. While that was talked about here, I can't believe many people were selling today because of disappointment about it. Everyone agreed it was a long shot at best. And outside of this small board, no one was talking about it, so it is hard for me to think that was the cause of the sell-off. This possibility was not touched on, so we have to guess that it does not exist. The reality seems to be official approval for HIV/NASH in three to four years, it will be four years. 1 year to get the trial set up with the FDA, EMA and all the centers actually carrying it out, 1 year to get it filled with patietns, 1 year for the alst patietn recruited to finish, several months for the trial data to be analyszed and several months for the application to be put together and then 6 months (since it is a sNDA) for the FDA to approve. and in the meantime working carefully with MSL to get some doctors to prescribe Egrifta to lipo/NASH patients that could get insurance reimbursment based on lipo diagnostic. But, at best, the lipo/NASH patients population is half of the lipo population 15,000/2 = 7,500 patients with lipo/NASH. Out of the 15,000 lipo patients, with sales rep promoting the drug, less than 1,000 are on it. So how much of the lipo/NASH 7,500 patients will start it without sales reps been allowed to promot it. 100 - 200 at best in the next three years? Hard to think it can be much higher than that based on actual sales of Egrifta with promotion. Add to that the intro of the F4 formulation and maybe it will help increase these numbers by 20% or something close to that. I think they can do better in the 7,500 with lipo and NAFLD/NASH (it may well be higher than 7,500). Lipo is viewed as a cosmetic issue while NASH is a serious health issue. I bet they can double their sales or mnore even just using MSL's and word of mouth amongst doctors. The presence of the talk around the clinics about the phase III trial will likely help in this regard too. If Dr. Grinspoon's article is a good one that gets a lot of attention, that will help as well.
So the next steps will be the publication of the full data by Dr Grinspoon with his analysis of their importance. Also, it seems that Thera did not meet with the FDA yet to discuss the way forward with Egrifta F8 and NASH. Maybe we could have some positive surprises out of that. Can they get orphan status for this indication with a much lower number of patients? It could speed up the process quite a lot. If they can get the number fo patients lower than the low end estimate of 300, that would speed the process. My guess is there is not a high probability of that since their consultants likely know what they are talking about. They could get an orphan designation but I am not sure that would speed the process up much. We should be thinking 4 years to get it done and that assumes weveything goes pretty smoothly, which almost never happens. Of course, all the other NASH drugs face similiar time frames and that is not stopping any of them from being valued for hundreds of millions, if not a billion, dollars. There is actually good reason for TH's NASH franchise to be valued higher due to its lower cost of doing the trials due to smaller number of patients and since it will have a monoply status, and the premium pricing that suggests, on their subsegment fo the NASH market.
Another question that I asked myself while listening to the call is if they are ready to start a clinical trial with the F8 formulation, why are they not starting the process to use it commercially? Are they keeping F8 for NASH for patent protection purposes? I have not been able to figure out their formulation strategy. Why so long to introduce the F4 (patent issues probably?). Why use the F4 if you are moving forward with F8 in HIV NASH? As far as I know, the F8 has not yet been shown to be bioequivalent with the original so I don't think it cna be used until the FDA signs off on it just like they dd witht he F4.
Finally, today's call is reitarating the importance for the company to have steady growth quarter over quarter with Trogarzo, and some meaningful growth from Egrifta with the F4 and full realease of the Grinspoon data. If they can achieve that, I don't see where the NASDAQ listing comes into play. It's a complicated situation for the company right now. They have some infos that they cannot disclose and infos that they don't want to fully disclose for strategic reasons. We need to understand that instead of crying.