RE:RE:RE:RE:RE:RE:RE:RE:Bloom Burton Yep it boils down to directional data versus empirical data. It's a very specific argument I'm having with myself. I totally get Paul's approach, the KOLs are on-board , the FDA is on-board, the company I imagine likes the risk/reward situation, I totally buy the idea that getting the perfect protocol in place might be the final piece of the puzzle, that was a big part of the past failings in NASH discussion. You all should go with what Paul is saying.
SPCEO1 wrote: The more you worry, the more we learn, so don't stop sharing those concerns. I do think your scientific backgrund may be limiting you ability to apprpriately weigh the positives in the directional data as a neophite like me looks at it and says we have a very good chance of success. But because I am a neophite, I could easily be underweighting the importance of data even when things generally look set up for a decent chance of a positive result.
qwerty22 wrote: After Paul listed all the data from NASH he called it "directional". To me that's in line with the way I've been thinking about this, and from my perspective the most honest he's been. I'm not implying he's been dishonest in the past. For me it encompasses both the very positive aspects of the data and it's limitations. I would read directional to mean that the data points in the right direction but doesn't exactly tell us where it's going to land. That is the foremost problem with not having a good Ph2 F2/F3 non-HIV biopsy dataset in my view. The simplest correction for that problem is to generate the data in a final Ph2. I agree that doesn't look likely now but it doesn't make the problem go away, I worry if the market isn't convinced now will it be convinced to invest $$$ in a Ph3 at a price we can swallow.
My other simple solution is they incorporate an interim data readout that has a stop/go aspect to it, allowing the Ph3 to end if the data isn't looking good, that effectively does the same thing as a Ph2 and allows the market to essentially invest in that interim data readout at this moment in time rather than the whole, expensive Ph3. I like that as a solution but Paul isn't talking about that.
The dream is there is a pharma waiting in the wings for THTX to complete this regulatory step and pharma $$$ pay for the Ph3, THTX gives up most of the pie for derisking on the cost of the Ph3.
The other obvious point is I'm just overstating this problem, I accept I'm trapped in this mindset. Paul has some very good points that make a lot of sense. I think I need to see the nailed down protocol to get out of this, I apologize for continually exposing you to my worrying.
scarlet1967 wrote:
Just listened again,
The NASH is too big an opportunity to pass on and they want a chunk of it which is something I have been saying for a long time.
The convertibles to be renewed or changed!
FDA wants to have an end of phase 2 meeting (“and that would be the end of it” no phase 2 or phase2b!).
The NASH EMA they just resubmitted the protocol.
The PDC for now shows great results.