Co3aii-- You are correct. The big thing that matters to the FDA in approving a Ph III application is the safety of the Ph I and II data. Yes, the FDA would like to see some degree of efficacy, but the efficacy decision basically belongs to the trial sponsor, i.e. PPHM and their BP partner.
If the trial sponsor believes the Phase II efficacy data is good enough to support a decision to throw mega bucks at a Phase III, then the FDA will say "be my guest, go right ahead," as long as the safety data is rock solid.
When we see the big PR (hopefully this week) on the re-constructed 3mg MOS data, the issue will be whether the 2nd line Bavi data, when combined with the pending front line data (that is open label), is good enough to attract a BP partner on very rich $$ terms, average $$ terms, or poor $$ terms.
The timing is working out quite nicely. The FDA approved Ph III trial design will come out of the EOP2 meeting 60-90 days after the application is made, which will happen within days of the PR being released. This means mid-May.
The front line NSCLC data is supposed to "event" in Q2 and will probably be released in some top line form for ASCO on May 15 even if a final MOS number has not been reached by that date.
It is the combo of (1) the 40 2nd line patients who got the 3mg Bavi dose with Docitaxel, plus (2) the 43 front line patients who got Bavi plus Paclitaxel/Carboplatin, plus (3) a look at Pancreatic subset analysis, plus (4) the earlier breast Bavi breast cancer results, that will collectively determine whether we get a very reach BP deal or an ordinary BP deal.
Going into a Phase III lung trial is not in question. Only the terms of the BP partnership are in question.
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