RE:RE:RE:RE:Sanofi delays BCG production to mid 2016...DY,
Officially a drug has to be able to stand on his own feet for the indication proposed by the sponsor. In my opinion the FDA can't publiquely imply that the MCNA would be a great backup to BCG in case of shortage. I would assume they can't and won't promote off-label use.
True that analysis like seeking alpha and others haven't really based their opinion on the potential help MCNA could get from the BCG recurrent shortage. Most of them simply base their opinion on the fact that DFS numbers are better than Valrubicin meaning a probable yes from the FDA since it's a high unmet needs (like John Ford from SA).
As for the advisory committee, the BCG shortage was not part of the meeting program and of the voting questions. Moreover, when Dr Walsh (one of the expert who voted yes) asks just before the final voting if they "could go ahead and say a drug should be approved so it can be use off-label" (see page 239), Dr Cripe, the chair person for that meeting (who also voted yes) answered with : "Let me remind you that we are an advisory committee. The FDA will be free to do what they wish."
And then Dr Walsh added : "I hear this. They're some compassionate things being said - but maybe we should have that in our decision-making and I can see with a shortage of BCG I can understand that should that be a consideration or should we vote on a question ? "
Here is the answer of Dr Witten (the FDA office director for that BLA) :
"I just would like to say I'm sure these considerations are in the back of people's mind of what it could be developed for and so forth but what we really are interested in is the discussion and vote on what the data in hand actually support. Just so to keep that in mind." Of course at that point she couldn't said : "of course...actually everybody this should be your number one consideration".
So the FDA clearly said to the panel experts to vote on the actual (rather large) BCG-failed indication. And that's what they did. But again i'm sure many of us strongly believe the FDA sees the BCG shortage situation as a good reason...if not the #1 reason why to approve MCNA.
M80