FY22 - It's all to play for here!

I don't know about you, but after reading the corporate update and then looking at todays SP movement - there are some clear games being played here...

What was good about the update?

FDA used the E word....... EUA, and agreed with Mesoblasts suggestion that it can be done, and how. It sounds as if MSB is going to fully pursue this EUA with Novartis for Covid ARDS now. TICK

FDA also provided everyone with a big clue as to why the Novartis deal has not closed yet, by stating that prior to a confirmatory ARDS trial the FDA must agree on the manufacturing assays being used. These manufacturing assays are linked to the GvHD trial, which is yet to meet with the tissue office and be agreed with. The FDA then said that the manufacturing for the BLA in GvHD is applicable to Covid ARDS, meaning they are tied together from an acceptable manufacturing standards point of view. I think then ( my opinion ) it's reasonable to assume, that right now there is not a clear path to approval for Novartis - since manufacturing for ARDS relies on manufacturing for GvHD. I am guessing here that one of the undisclosed closing conditions, is probably approval or agreement from the FDA on trial design..... Well the FDA has just agreed that EUA is a possibility, and that FDA said it must agree with the GvHD assays before another Covid trial commences if you want an EUA. So we can assume Novartis is waiting for the Tissues office to approve the assays, meaning manufacturing for Covid ARDS is a go. This is the most likely reason for the delay in Novartis up front payment IMO, if they didn't think it worked, they would have already walked. Clearly they would want a path to approval, and Tissues office comment provides exactly this. Expected Q4.

FDA said the current proposed assays in development appear reasonable , and the in Vitro MOA appears well established. This is a big shift from the FDA in the GvHD meeting. They never said before that the assays were reasonable or had well established in vitro actions.... instead they were trying to invalidate the assays and the MOA TNFR knock down method with talk about using alternate cutting edge science like surface scanning. They have come round.... I think based on the FDA comment - the Tissue department is going to be more likely to approve. So I think in Q4 we will get another massive TICK. Agreement on GvHD manufacturing and re-submission for full approval within 6 months. Novartis deal likely to close within a very short time from the Tissues department meeting, and the race for Covid ARDS EUA begins - this time with Novartis running the trial / end points etc...

MSB are also awaiting feedback on submissions for CHF and Back pain, also all due in Q4. The CLBP may trigger Grunenthal milestone payments, and will probably lead to a meeting with the european regulator in order to get support for a single US run trial to support full approval. This is the sam product used in both trials, so again any manufacturing lessons / product assays learnt from GvHD, will be used by MSB to get these two over the line quicker. Expect the back pain to require another trial ( run probably in conjunction with Grunenthal ) , and CHF....... MSB previously mentioned the EUA word on the CHF trials.......... I'm holding my breath, let's see what the FDA has to say about it....If that happens we will have 2 candidates looking at EUA in 2022 and a BLA for GvHD.

In summary...... that OTAT feedback really points towards immediate GVhd re-submission for full approval, and phase 3 COVID ARDS trial design with Novartis, and probably Novartis closing conditions approved.
The Rexlemestrocel feedback will indicate if EUA for CHF ( or CLBP ) is possible, and if not weather there is currently enough evidence to apply for full approval. - although I would be thinking CHF is the real dark horse here, but with the opioid issues you never know, they could both be.

Far from a nothing burger.... the end of year results reveal the FDA likes what it sees so far for the potency assays, and Q4 is going to be one hell of a quarter, maybe the best since the companies inception.


What is the share price doing today..... who cares, lots of people woke up today, and looked at the share price first then read the article.... they are really gamblers at heart..... maybe deep down we all are.