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Ann: Mesoblast Type A Meeting with FDA, page-112

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dolcevita

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22/09/23

11:00

Post #: 69974908
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Originally posted by Fastback6666: ↑

I always appreciate your posts and I am usually always optimistic of MSB.

However:

It definitely seems like the relationship with the FDA is not at all rosy as the FDA are not doing much for MSB here.

MSB are going to generate new potency assay data in coming months on their phase 3 trial but no where in the announcement says that the FDA will review or accept this for any paediatric approval. MSB may want this and we may hope for it but if does not say anywhere that the FDA will look at it for fast or slow paediatric GVHD approval.

The only real thing the data generated will do is to try to link in with the Adult trial so that when it completes the hope is Paediatric can be approved and Paediatric with it. Otherwise we may only get approval in adults on completion of the new trial as FDA look to have said potency assay still has not been proven for the phase 3 paediatric trial - which is highly disappointing after all this time.

The only thing MSB have said the FDA will do now is review their registrational trial design for an adult trial in aGVHD. That is all that is happening now - progress to an Adult trial for aGVHD to prove some potency assay to current commercial stock.

After all this time it does unfortunately seem like MSB are saying “FDA look at all out data”. And FDA and saying meh don’t want it and just give us a new trial design and we will see. No one can read any more into it than what is in black and white.

Why MSB see their data as convincing and correct and the FDA don’t - no one will know. I fear some Ego’s are at play around data and process which is sad to hold up Paediatric approval here.

We move onto the adult trial and hope the company can survive that long.

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It's always darkest before the dawn.

If what FDA is doing is unreasonable they can be challenged legally but MSB hasn't wanted to do this, and only done as a last resort.

FDA kicking and screaming but I believe logic will prevail.

MSB Price at posting: 37.0¢ Sentiment: Buy Disclosure: Held
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Ann: Mesoblast Type A Meeting with FDA, page-112

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Ann: Mesoblast Type A Meeting with FDA, page-112

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