Doesn't that raise some red flags? It sure looks to me at the least they will need another ph2. If this drug was so important to the cancer center in Tampa, why so slow enrollment? No one in two years stepped forward and partnered this drug?
I'm sorry I want to believe, just cannot. If you take the greed out this equation, the math just doesn't add up. I understand you only want to hear what you want to hear.
Since they don't have robust OS data yet, I believe that if they can get BTD and/or AA, with an additional small study demonstrating good data on surrogate endpoints that qualify for BTD and/or AA (such as ORR, PFS, tumor shrinkage etc.), then they ccould potentially be gratned marketing approval under these accelerated approvals paths...they then likely ask them to do a longer Phase 4 post-marketing study to look at OS to make sure that the surrogate endpoints ultimately correlate with OS.
please explain what greed and what math.. Im not sure what your reading comprehension skills(to me they seem a bit laking), This is no additional p2 or p3 study. there may be a bridge study,which is generally very short to provide data regarding using multiple treatments. They are doing multiple treatments in the compasionate use program but are not allow to use that data as study data(FDA rules), so they will have to do a small study similar to the compasionate use program to collect the data(if and only if the FDA asks for it). As for partners, pfizer has to execs on the provectus advisory board(on of which is a merger/aquisitions guy)
I agree that this drug had better do more than reduce pain and bleeding. PV-10 needs to get out on the market. It can statistically be proven that PV-10 significantly faster than proving PV-10 extends life (technically, complete removal of a tumor is just a symptom, too).
Yes, there is a certain amount of belief required at this point. Otherwise, this would be a multi-billion $ company now. If this week proved anything it is that the potential of PV-10 has a high upside, but many people are reluctant to say it is proven, despite it stellar record on nearly 500 lesions. If you wish not to believe, that is your choice. Do you stay on this board so that you can be convinced otherwise, or to dissuade others from the risk?