Mesoblast stock(rock)-take March 2024, page-128

thanks for sharing @stokdog

I think particularly relevant to the recent FDA notification is the following in example G:

TYPES OF CONFIRMATORY EVIDENCE
This section provides examples of types of confirmatory evidence that can, in appropriate circumstances, be used to substantiate one adequate and well-controlled clinical investigation to demonstrate substantial evidence of effectiveness.

the relevant information example G



I have also been focusing a little on SI's use of the phrase 'collaborative approach', which i interpret as the following:

SI: Given the last two CRL's, we are desperately keen to receive definitive direction in relation to what is required to meet the FDA threshold for approval. Here is the latest additional data re potency assays, can you please review and provide direction based on the information we have made available so that in submitting a BLA for the third time there are no apparent gaps, which would be company destroying
FDA: following additional consideration of the available clinical data from phase 3 study we believe it is sufficient to support submission
SI: thank you for your collaborative approach. The responses and guidance from the FDA are clear and provide us with a high level of confidence


DYOR not meant to be financial advice

Cheers
V