Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-451

I am still a bit bemused by the wording of the announcement.

”FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission”

Note - not “data”, not “new information”, but “consideration”.

Were the FDA head honchos having a round of golf, and decided amongst themselves that they had been a bit hard on the Aussie battler? Then back to the clubhouse for a scotch or three.

Or perhaps Big Pharma have “advised” the FDA top order that Meso's gonads have been squeezed enough, so give them a win that also allows BP to make a cheap TO?

Don't get me wrong. My wife is very happy to see the reverse in fortunes, and so quick after that dilutive capital raise too!