Upcoming Newsflow & Re-rate Estimations, page-47

Hi Newbies and @Hawk70

Welcome aboard.

As per a past post of mine.

I think next catalyst will be MSB receiving formal minutes of their March FDA meeting in 20 Days (Approximately the 25/26th April) and then MSB quickly relaying and announcing the core FDA confirmations from
the FDA minutes on the ASX on the exact next steps in the progression of the Adult aGVHD trial and also hopefully agreeance of their potency assay approach for the trial and potentially elaborating a little more on their potency assay data to be submitted in the peads aGVHD BLA.

A Double confirmation on MSB’s potency assay newly minted patent and assay approach to the new trial will help derisk even further the Paeds aGVHD BLA resubmission that is to occur this quarter as well as drive even more confidence that the FDA are truly happy with MSB’s potency assays for ultimate approval of Paeds aGVHD Ryoncil in the second half of this year.

Meanwhile the Adult aGVHD trial can kick on through this year.

I hope soon after the next announcement we then see the formal submission of the peads aGVHD BLA submission and that is has been ‘Accepted’ by the FDA(Not Approved)..accepted for their review…and hopefully ultimate approval. Though this announcement can actually come any day - I would expect they still need to fine tune it all with the FDA again and ensure what is submitted is correct so I don’t expect to see this BLA submission until June as it is still hundreds and hundreds of pages in the submission.

Cheers - DYOR and not financial advice.