FTM - Upon reading the FDA link provided by Thurly the following sentence from the acceleragted approval section sticks out:
"In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer. These studies are known as phase 4 confirmatory trials."
It appears to me that the FDA is saying (or least implying) that AA is only granted on surrogate data generated in phase III studies.
It seems we may have to wait a little longer for FDA acceptable AA data to be generated for sumbittal if required to be based on or, at the least supported by, PIII data.
What is your take on this?
It true that we have to wait until PIII data is generated, then so be it. This doesn't worry me all that much because it doesn't change the facts from what has occured (and still is occurring) in the all the PI and PII studies. Bavituximab has been and continues to be validated as potential BLOCKBUSTER drug for multiple cancers no matter what the red herring fishmongers keep pushing on this board.
It will just make me pay closer attention to the questions being asked of the company re: how they intend to finance the next NSCLC phases. It looks like we may need a partner more than I anticipated. Personally I think the continued strength of the data from the trials will support the share price to a point that would be much more appreciated by us and help fiance some more of the ATM to allow the company to show more strength in the negotiating process when seeking a partner. I would expect that whatever short term price rise we see the company will need to sell shares into it (hopefully later than sooner) to help with this negotiating process.
Does anyone have any guess on what type of money it would take to get PIII data for whatever surrogate data would be used to support AA? I would assume they would be using ORR as a first choice and wouldn't that take at least 8 weeks for eache patient plus a couple of weeks for data collection. Then have to consider enrollment time for the patients but I don't think enrollment time strected out is the real money drain; just the actual patient enrollment and treatment which is bsed on numbers.
Hell, the dilution has already been substantial and at least I have kept the faith and kept buying in the beatdown lows. May not have been the smartest thing but until the trial results start showing me otherwise I can't see how this is a loser even with more near term dilution (based on my belief of what the market potentials are).
