This is from "MESOBLAST REPORTS FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS
FOR THE PERIOD ENDED MARCH 31, 2019"
"
Mesoblast Chief Executive Dr Silviu Itescu stated: “We achieved a significant corporate milestone by initiating our
first BLA submission to the FDA. We will focus our efforts on launch activities in preparation for our first product
roll-out in the United States, and on our supply chain to meet the projected market demand for this and our
follow-on products.”
Recent Corporate Highlights
• The United States Food and Drug Administration (FDA) has agreed to a rolling Biologics License Application
(BLA) review of remestemcel-L for the treatment of steroid-refractory acute Graft Versus Host Disease
(aGVHD) in children.
• Mesoblast has initiated the rolling submission of the BLA to the FDA, with filing of the first module. The
rolling process will provide opportunity for ongoing communication, and during this process the Company
expects it will be able to adequately address any substantial matters raised by the FDA."
Here is the details and questions that were discussed at the ODAC meeting:
https://www.fda.gov/advisory-committees/advisory-committee-calendar/august-13-2020-meeting-oncologic-drugs-advisory-committee-meeting-announcement-08132020-08132020#event-materialsLook closely at the 'final questions' contained in the link above.
I reasonably deduce that MSB knew there were 'concerns' with the FDA regarding aGVHD that were flagged prior to the report of 31 March 2019, as above. And this was the approach: "The rolling process will provide opportunity for ongoing communication, and during this process the Company expects it will be able to adequately address any substantial matters raised by the FDA."
The questions tabled for the ODAC meeting (August 13 2020) were the 'substantial matters raised by the FDA'. Now ask yourself (after you read the questions in the link above), in your opinion, do you believe MSB has 'adequately' addressed ALL those questions? The answer is no. MSB has not addressed them adequately enough for the FDA, in their opinion.
It's difficult to disagree with the FDA. Now MSB is going to try another way via their processes. I'm hopeful but I am left wondering how MSB went into the ODAC meeting not knowing the FDA was going to knock back the trial?
How the hell was SI clueless??!! Here's a question I would of asked in 2019: Have we satisfied your reservations and if we have not, what should we now do to satisfy them?
There is one thing worse than putting off the aGVHD salespeople now. And that is putting them off at a later date.
Hindsight gives 20/20. If you look back you will find the answers. The chances for aGVHD to fly are very low (without another trial AND a whole raft of other safeguards outlined in the ODAC questions). To think otherwise is reckless and bad business!
What has changed on the MSB side since the FDA decision? Answer: nothing.
Roll it back now. There is only a very small chance it will get up.
(20min delay)