RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Sorting things out a bitpalinc2000 wrote:
Qwerty your being a scientist with far superior knowledge than JFM has cast a big shadow on mr KIA ( Know it all).... His putting you on Ignore is a cowardly move which should be condemned by other posters but am afraid nobody will say anything
Please keep posting your thoughts in search of the Truth!!!
No hype no bashing !!!
qwerty22 wrote: Erm do we speak a different language? I thought our two versions of a 2/3 were essential identical. What did I get wrong? I think this relationship is not working, I guess you ignoring me is the best scenarion at this point ;)
jfm1330 wrote: Turn it the way you want, it looks like at IIb/III would add at least a year and a half to the trial.
qwerty22 wrote: My understanding is there is no set definition of what a 2b/3 is. But as the name suggests its usually a trial that has 2 stages. The first is to prove something maybe missing from the phase 2 data or if you see potential in a new dosing regimen or something other then you test that before driving into the 3. You complete that first stage and you transition to 3 immediately on proving to the fda you hit the goal. The advantage over a straight 2 is you dont have the delay we are experiencing now between 2 and 3 and you already know exactly the target you need to hit. The disadvantage is you essentially have to still complete 2 trials and the 2nd cant start until the 1st reads out.
The easiest explanation for what our first stage might be is stronger data on the fda endpoints in late stage nash, you could bundle that with trying out needless injections if they want to go that route. But it would, it seems to me, involve enrolling a smallish cohort and drugging them for 12 months and biopsying so you are looking at maybe 18 months extra time. Those patients can maybe be bundled with the data from the phase 3 in the final analysis so you shave a little time off the phase 3. If anybody has a better understanding of what 2/3 is I'd like to know, any better idea what the practicalities in our specific case might be?
In short I think it has clear advantages over a straight 2 but its not the same level of endorsement as a straight 3. (If it was then just call it a 3)
SPCEO1 wrote: The Liver Therapy Forum has suggested the phase IIb/III idea so that is why I am referring to it. TH did not suggest that back in June but when I asked the company about the LTF's suggestions (which go beyond just the phase designation) the response dodged my question but complimented LTF's analysis. I am not qualified to weigh in sensibly on this issue. But a phase IIb/III can be a regisyrational trial, so I am fine with it. Is there a shortcoming to it being labeled a phase IIb/III that we should be aware of?
jfm1330 wrote: Just as a reminder, the company never talked about doing a phase IIb/III. This is something that was put forward here. So the goal is a straight small phase III according to the company.
That guy is trash hes on other forums, if you disagree with he doesn't like coward is right. Wino, qwerty and you are only worth reading