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Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-254

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Phaedrus

1,440 Posts.

3148

13/03/24

06:00

Post #: 72857756
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Originally posted by Blackkkkkkk: ↑

Hi All

Thanks for all your replies, and yes, my question was in relation to the approval pathway for gvhd for kids, in a hypothetical scenario where the FDA accepts in the upcoming meeting the additional potency assay that's been provided by MSB as satisfactory response to its complete response letter. Sorry for posting this question in the wrong thread (must have been the reason for the confusion), but I just wanted some clarity on, in this hypothetical scenario:

1. Does MSB have to submit a new BLA including the additional assay and be subjected to the normal review period, or does MSB have the benefit of a rolling review for gvhd for kids as well?
2. In either case, what would be the anticipated review period by the FDA to grant full approval on gvhd for kids?
3. Assuming FDA is not going to approve gvhd for kids "on the spot" (i.e. at the meeting) as it will be subject to a review process, what is the "best" ASX announcement that we can expect to hear from MSB after the meeting?

Expand

I think you'll find answers to many of your questions here: https://www.fda.gov/media/84417/download

Regarding content of any post-meeting announcements, we'll have the real thing in short order, IMO.

GLTAH

MSB Price at posting: 39.5¢ Sentiment: Buy Disclosure: Held
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