Based on this, there should be some good news in the next month or two.
Last time the FDA provided feedback about the potency assay, it was also the time when the meeting on the heart failure application in LVAD patients took place. Don’t quote me but from memory, the FDA has some operating rule whereby they wouldn’t be having meetings on a second drug or treatment if a decision or important feedback is pending on a first one. If this is the case, then once the GVHD decision is announced, expect the long anticipated pre-BLA meeting for heart to take place very soon and the format should very much be based on the fastest path and the one that yields the best outcome for the three heart indications, collectively and individually. Remember they are now being discussed as part of a continuum.
Not advice. DYOR.
MSB Price at posting:
$1.67 Sentiment: Hold Disclosure: Held
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