When you say "at the time of ODAC that was all the data MSB represented on the data," given that it is in my opinion a very broad statement, I want to make sure I understand exactly what you mean by that.
- All the data they had analysed at the time?
- All patient data available to them (improved manufacturing process, all trials and - this is where we may disagree - other SR-aGvHD studies where no such data was measured and could have been included, but wasn't)?
The link that I pasted from MSB mentions specifically "Emergency Investigational New Drug (EIND) protocol from 2015-2023" (https://investorsmedia.mesoblast.com/static-files/adfc1ba0-bd4d-47bd-b0a0-a0b3516b0520). I believe they would have had access to the data already, but at the time, the focus was on showing that trial GVHD001 can be considered a well-controlled trial. Once they got the FDA presumably to agree on that point, CRL #2 asked for further data to show that the stockpiled product is the same as the one used in that trial. I think @Bazsa was also saying something to that effect.
As I mentioned before, the 11 data points could be a hindsight 20/20 issue and only really became an issue once they had the FDA in a position to consider accepting that the last P3 trial was acceptable.
You did mention in a post that you'd be happy to considering a bet, as long as you can trust the other party and if your privacy is respected (https://hotcopper.com.au/threads/pick-todays-price-range-low-high-just-for-fun.7975502/page-134?post_id=73665411). Given that a commercial benefit can not arise from posting on here based on the HC T&C fine print, Im happy to offer you the following:
If MSB gets approved (any type of approval even if it includes a P4 trial), I'm happy to transfer you $100 in the form of a gift card of your choice (not enough to be considered commercial in my eyes, but I could be wrong). If there's a CRL #3, provide me with a burner email address to send it to.
If they get approved, I ask you to buy shares in another stock I have been researching at a value of your choice - but at least $100. That way I know you will also have a look at that stock and share your opinion on it (which I would be very interested to hear).
Let me know if you would be willing to agree to these terms or prefer adjustments.
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