if MSB did that, they would essentially be admitting defeat before the FDA made a decision.
the FDA also cannot give any indication on their decision throughout the review process.
it’s a very formal process and boxes ticked and steps are followed to the tee, no deviations allowed. That is how it is.
now the FDA could very well have the idea in mind that they would entertain another BLA for AA, but they can’t say that during the review. But they can at the Type A meeting.
I’ve seen the FDA reverse their decision at a Type A meeting as well, but I’m not suggesting that will happen in this instance. AA pathway sounds like a realistic outcome.
Insider bullish on MSB prior fda approval, page-28
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