Agreed... but as happened last time when everything appeared......

Agreed... but as happened last time when everything appeared... and could support approval, it did not.

For CHF, if you read the announcement carefully....... FDA may never have actually used the words accelerated approval IMO. I'm not 100% sure.

""Feedback provided to Mesoblast regarding potential pathways to licensure for rexlemestrocel-L, FDA’s comments indicated that the presented results may support a reasonable likelihood of clinical benefit of MPCs against mortality in LVAD patients, consistent with the criteria for accelerated approval.""

Is that MSB stating that this is the criteria for accelerated approval or FDA ? To me, the FDA stated italics, and MSB have inferred the criteria ( which are factual in either case) so in theory the point is mute weather FDA said it out aloud or not

Perhaps the key word is the repeated use of the words " may " , which happened prior to CRL1 and CRL2.


Also on GvHD.. the company has mentioned answering " other outstanding items " in the CRL. We dont have any idea what they are, and unless they are all 100% answered to FDA's liking, CRL3 could be a few months away. It is a possibility not many like to admit, but one that nobody outside the company has the slightest idea on the likely hood , or what the other issues are.

If I compare this CRL to the one given to Botanix recently, Bitanux appeared to have conveyed 100% all the issues raised in the CRL to shareholders, who have a good idea now how likely approval is. For MSB it is not 100%, and impossible to guess even what the % is without having a clue what the other items are.

Here is hoping all CRL points are in the bag so to speak.