RE:RE:RE:RE:From hereI am in agreement with your vision SP.
Part of the share price fluctuation may be some holders exiting as the picture for the company changes from one maximizing current profits to one building a pipeline and chasing bigger profits down the road.
Hint #1 came with the purchase of Katana. This does nothing for holders that want TH to chase profits right now,
Hint #2 was the focus on NASH on the most recent conference call. The focus was not on current earnings (or lack thereof).
The company has to make a big pivot here and some shareholders will decide that the risk/reward profile has changed.
Personally, I see the reward as potentially much greater and the risk up. Overall, I see a higher share price and gush is why I added a few more yesterday.
I saw a NASH image showing 40 companies working on NASH drugs....no sign of TH.
That should and needs to change in the near future.
bfw
SPCEO1 wrote: MDGL's patent expires in 2033 and they have no way of extending it further. TH's F8 patent expires in 2033 and they can extend it as you have pointed out. So, as long as F8 is bioequivalent to original Egrifta, TH is actually in a better patent position than MDGL. But they may not bother testing F8 for biequivalence if they are going for a whole new extended release version of it, or some other twist, that will give them patent coverage out until 2040. Then they would just test that one for bioequivalence. Who knows what they may have already done on this front? My guess is the bioequivalence hurdle is not a big one. So, I actually think TH's patent position is stronger than MDGL's
We do need to see the full results to do a more thorough comparison to MDGL but we do know the relative liver fat reduction was a bit better for TH than MDGL and that TH reported that a high percentage of patients (probably over 50% of responders) saw their liver fat levels return to normal (less than 5%). MDGL did not mention anything like this in their report and if I am reading the info correctly, they saw liver fat fall in absolute terms by 10% (from 20%) on average. I imagine they had some patients that also returned to normal liver fat levels but they did not highlight it so I am guessing it was less than seen with TH. So, basically, we do need to see the full data set to make a decent comparison but we have some strong hints that the comparison will be a good one.
On Europe, approval is just a formality now given the Scientific Advisory Group's positive recommendation. The real question is how much profit can they generate from Europe? Since sales in the US have been a struggle, that is not a good sign for Europe. I am not counting on too much from Europe and I don't think the market is either.
On Trogarzo, it is pretty clear the launch was less than hoped for. While they may stage a good recovery from that, and there are signs of sales improving, it is not likely that Trogarzo sales are going to reach fantastic levels at this point as it is rare when a drug bounces back strongly from a weak launch. About a year from now, Trogarzo may also be facing competition from a pill from Viiv, so that is not going to be very helpful either.
I agree TH investors need to be a bit more patient but I think we already know with a high degree of certainty what the outcomes will be in some of the things you mention. In another month or so, if TH keeps to its schedule, we will know even more about their NASH strategy, which is key to the company's future. So, we may not need to be much more patient.
jfm1330 wrote: I don't understand the lack of patience here. The company needs to get approval in Europe, secure NAFLD/NASH application patent in the US. You cannot compare Thera to MDGL as long as you don't have a confirmed strong patent position and full results from Grinspoon. The company is also just starting to sell Trogarzo with everything in place to facilitate the job. Add to that that we wait for the introduction of F4 formulation of Egrifta that should also help a lot since F1 is so bad.
So we are in waiting mode for many very important milestones, and the market is waiting to see if Trogarzo will finally take off on a better trend. We should have the answer to all that in the next six months, and for most, earlier than that. So patience is still required. It is pointless for the company to go out on a promotionnal mode with so many question marks still unanswered. In six months if they have Europe for Trogarzo, F4 for Egrifta, some positive news about NAFLD/NASH (patent, label extension, clinical trial), then they will have a compelling story to tell, and that should lead to a NASDAQ listing by the end of the year. But we still need patience and faith in positive outcomes on all these potential value drivers.
The actual situation reminds me how we were impatients when waiting for phase III results and BLA submission on Trogarzo and during the FDA delay in the priority review of the BLA. When the good news finally came, the SP responded positively. It will be the same this time around if we get positive outcomes on the upcoming events.