RE:Intercept slips due SAFETY of OcalivaThis highlights a significant benefit that THTX has and should pitch like heck in their books, and that is
SAFETY. I don't know what the appropriate weight of safety versus efficacy should be in analyzing the progression of a drug through trials, but it seems in NASH they have been sort of equal in all the various failed trials. Gilead's ASK1 inhibitor had no efficacy, same for Genfit's PPAR and a few others (Takeda/Shire, Conatus, etc...). Safey's hit back a few others too along with Intercepts FXR, but it usually hits the trials earlier in Phase 1's and 2's. As I said yesterday, Akero's really not yet gotten over the safety hurdle on their great numbers, but it still could in the next trial.
If we assume it's a 50/50 safety/efficacy split in the risk of failing a Phase 3, then THTX should absolutely be full throtle highlighting they are past that as the drug has a 10 year track record with nothing. That is really worth
a lot in terms of discounted market cap and valuation. Just mathematically it is, with no argument.
So you can say that all THTX is left with in this Phase 3 is efficacy. They need to really lay out everything they have as far as efficacy. They've got the pieces of the puzzle there, but have yet to really put it all together in a powerfully convincing way, like what Qwerty laid out the other day. But it really should be easy for them to do that. They really do have many of those pieces and have large studies from KOLs that support the basis of their case around the loose ends. It's never 100% for any of these drugs until you finish Phase 3, but they have every reason to be as hopeful about the MOA of tesamorelin as any of these guys have for their approaches. And at this point, the furthest along NASH treatments are all now the "fat-buster" approaches and they are one of those now. The anti-fibrotics have really faded bigtime.
This likely spells the end to all the bile acid approaches. I think they're laying off 20% of workforce too.
scarlet1967 wrote: "
They seem to have major safety issue with their drug and significant negative cash flow!(cash burn between 60 to 70 M per quarter)
ICPT market cap 1,25 B VS THTX 172 M??