Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-536

Thank you for pointing me to the patent. I was in fact not aware of it.

As you said, "already known", and I think it is worth mentioning that the patent still refers to Danilkovitch (Osiris at the time, involved in developing the potency assay) and references Aggarwal, which was one of the main factors that led you to (correctly) believe that CRL #2 was to happen, due to data sets being to small to rule out other confounding factors including IFN-γ (also mentioned during the ODAC meeting):



https://patents.google.com/patent/US20210171913A1/en?q=(Mesenchymal+Stem+Cells+expressing+TNF+alpha+receptors)&oq=Mesenchymal+Stem+Cells+expressing+TNF+alpha+receptors

Without going further into this though, first of all I'd like to congratulate all MSB shareholders that stuck to their guns when the SP dropped to the mid 20s, including (especially) the ones that took up their entitlement offer during the cap raise that had a non-reounceable right issue attached to it, when the SP price was below the CR price. It took Cojones the size the of wrecking balls and you deserve the rewards reflected in the current SP.

Regarding the potency assay, I believe MSB's "game" was not necessarily what has been announced to the public by announcing running the adult trial etc., but (more or less) secretly getting the FDA to reverse their comment that the trial in children was not well-controlled.

Why?


https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02732146-3A629509

AND/OR

If the FDA agrees that the trial conducted (and met its primary endpoint) was well controlled, the adult trial ("provide further evidence" could be considered optional.
By playing along and showing that progress has been made (filing updates to the original IND, confirm that the products are the same, noting that the current process is even superior to the original process), it makes it potentially easier for the FDA to agree and not lose face regarding CRL #1 and #2, as they can claim that they led to an improved potency assay etc.

And recently, MSB announced that during the Type A meeting:


https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02767661-3A635533

Based on the last announcement:


https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02788939-3A639451

Given the absence of new clinical evidence in the form of a trial in adults and the emphasis of "met primary endpoint" and "well controlled", I believe they got the FDA to agree on that now given MSB has made additional improvements. A Phase 4 trial (after approval) however is likely in my opinion.

And once they have gained approval, MSB's original plan to get into the adult market via label extension is potentially a few months away instead of an adult trial plus a few months.

All just in my opinion.