How close is close though?
6months, 12months, 2 years, 3years….more
Nothing in this space is quick that is clear form past “short order” comments from Si.
If we hear the words “short order” from Si again I think most people will want to strangle him.
I believe in the science and believe in the products in train but MSB have mislead or mismanaged here and how much more mismanagement will occur is my very real concern.
Just the simple fact that over the past 4 to 5 years MSB have said they have a good relationship and have been working closing with them….the raw proof was there on Friday that this does not at all feel like they are working closely with the FDA - the only exception is if the FDA are purposely making this very hard for MSB for other motives.
Has the FDA just responded to the binary second BLA request that most are suggesting here - Approval for aGVHD in all cohorts …..The binary answer is no not yet as you don’t have data on them all. Provide it!
While an easy answer for the FDA that is a killer blow to MSB investors at this point in time and I knew it would be but expected MSB not to mismanage the resubmission.
My thoughts are undecided as yet around where the blame lies most or where to next.
What is clear is that MSB and the FDA are not working closely together and Si cannot claim that anymore.
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