Ann: Appendix 3G and Appendix 3H, page-44

I think you shouldn't mix the FDA decision with Novartis.
Novartis was acting as a corporate investor in this case. The fact that they saw FDA kept on challenging MSB's response does not mean that we won't be able to get an approval (no one knows that for sure, only the FDA can decide). From an investor's point of view, Novartis didn't pull out immediately once the Covid trial was terminated, they've waited for almost 1 year, which may indicate that 1) Novartis did see the value of MSB 2) the decision to pull out was not taken lightly or it was a 60 (terminate): 40 (stay) kinda decision. If the decision was >70:30, they would have pull out almost immediately after the trial was terminated. Come on guys, Novartis VC team is super busy with double digit Billions of dollar to invest for their future growth, they wouldn't waste time if the decision was a clear NO.

FDA is acting very cautiously, the fact that MSB was not allowed to start the second C-19 trial until the CMC has been ironed out (from the SR-aGVHD trial) means that they think this is the most important attribute. Harsh, but fair enough, they have NEVER experienced something as complex as MSCs. all products on the market: drugs, antibody, proteins, radiation all have a very clear CQA! something they understand and can check for consistency and quality. I am not saying MSB hasn't provided that, I am saying they haven't accepted what MSB had offered.

If you think SI screwed up, the question I ask you is even if we have a positive result for C-19 trial, would the FDA approve the product, given that the CMC and CQA are still not satisfyingly addressed in the FDA's mind? The FDA is thinking what happen if we scale up the production and the effect of MSC drops, because we have no idea what is the CQA is?