After BLA submitted then FDA has minimum of 60 days to get back...

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RickyH

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28/11/19

09:21

Post #: 41676686
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Originally posted by stanjupiter: ↑

I went to the AGM. It was really good to meet up with some other HC posters. Def agree - really nice group of people.

This is my take but feel free to add or correct anything. I'm a bit rushed as I have to go out and writing up from my scrappy notes. From SI's talk:

Remestemcel-LAfter BLA submitted then FDA has minimum of 60 days to get back to MSB but if approval is granted, Remestemcel-L will be on market likely 'some time during 2020'.

Reimbursement will be decided in the light that one child with SR-aGvHD can cost 500k for intensive care. They typically spend 3 months in ICU and getting them out 60 days earlier will deliver significant cost savings.

SI really stressed no evidence of infections or other complications; the cells have so far proved very safe. This is important imo because of SI's background as a medic and his integrity.

Particularly of note to me was the stress on the potential for other applications for this candidate. SI mentioned Crohn's Disease in his talk, which I thought was important, because the company rarely mentions this and it's a huge market.

CHF

I personally thought SI sounded really confident about this. Trial has had 9 DMC reviews and always recommendation to continue. No safety issues. And 1/3 of way through independent analysis saw meeting of primary end point (I hope I heard that right!), so if the trial continues there's a very strong chance of a positive read out. I asked a question to SI about CHF results and if they were really good, would that mean that our product could be on the market reasonably quickly or would there still need to be a confirmatory trial? If I recall right, he said that approval could be granted on the basis of really good results but obviously it all depends on what those results are.

I was really glad I went along. I like this company. I find them professional but unpretentious - Authentic is a word that comes to mind. SI really knows his stuff at a deep level and I'm happy with his leadership b/c we'll be liaising with doctors in acute medicine who are at the top of their game and are not easily impressed. I think they'll be impressed with our company.

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After BLA submitted then FDA has minimum of 60 days to get back to MSB but if approval is granted, Remestemcel-L will be on market likely 'some time during 2020'.
My understanding of the comments made by SI is that once last section of BLA has been submitted, the FDA have 60 days to get back to MSB to report that the filing is complete (not give approval). The FDA then has 6 months (fast track) to consider the submission to determine whether to give approval. I will be happy to be wrong with this interpretation, but that is my understanding of the FDA approval process.

MSB Price at posting: $1.84 Sentiment: Buy Disclosure: Held
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