Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-51

@manishv. You may recall that the Company has already passed its manufacturing inspection in Singapore . The key outstanding issue in the 2nd CRL is understood to be the potency assay. In my opinion, it is now highly likely that the new data linked to their revised proprietary assay being used to determine product characterisation and batch consistency , has now been deemed “reasonable” or fit for purpose by OTP and therefore Mesoblast has now been encouraged to refile its BLA. This guidance would most likely have been offered in formal written responses prior to the well publicised forthcoming meeting with the FDA. Best possible outcome from my perspective. Shares are likely to rerate over the next 3-4 months. Pharma will be watching …fantastic news. Congratulations Silviu and the team .


Please do not rely on the facts or opinions contained in the above post when making an investment decision . OP