MSB to dispute FDA finding in Type A meeting, page-810

WELL PLAYED NOVARTIS

1. Mesoblast trial for GVHD is a success

2. Mesoblast is granted BLA with priority rolling review. Impressive.

3. Novartis/Incyte could be under threat for their blockbuster treatment Jakafi.

4. Novartis doesn’t want to just block Rem-l from approval, they want it for themselves. It

works. Well. With no safety concerns.

5. Strategy - to block approval first, then partner when Mesoblast is backed into a corner.

6. Maybe they even approached Mesoblast to partner for GVHD but were knocked back by SI early days?

7. Covid hits. 10 out of 12 patients leave hospital after receiving Rem - l.

8. Mesoblast gets 50M fully funded, double blinded RCT.

9. Novartis now takes notice of potential ARDS treatment.

10. Rem-l dampens cytokine storm in GVHD already proven. They want it.

11. Rem-l dampens cytokine storm in ARDS - they want it for all cause ARDS

12. Lassman (expert in FDA law) known to Novartis for over 15 years then drops the mother of all blocks.

14. FDA goes against ODAC vote of 9-1 for first time ever in 16 years.

15. Well played Novartis

16. Mesoblast gets knocked back at type A meeting.

17. Time to strike with a partnership. Disguising the deal by putting ARDS as the headline act, hiding their original target – GVHD - in the background.

18. C19 trial fails to meet primary endpoint.

19. Extension of cooling off for 90 days.

20. The failed trial is perfect for Novartis as they now have time to see what the outcome of the dispute resolution for GVHD will be. Knowing there’s a chance of getting approval with an additional trial in adults attached. See here - https://hotcopper.com.au/threads/msb-trading-2021-paradigm-shift.5840628/page-786?post_id=50220790 - thanks @ddwn

If approved Novartis will then be seen as the hero by stepping in and funding the additional trial because, you guessed it, they want it. Bad.

21. They also gain access to the fully funded ARDS data from the C19 trial to confirm the results from Mt Sanai.

Well played. Ching ching.

Novartis didn’t sign a billion ++ deal for C19 ARDS. They want Rem-l to treat children under 12 and later for adults once confirmed by the additional trial because Jakafi blows and they know it.

The results for GVHD were so impressive that all Novartis needed was the outcome of the Mt Sanai 10 to give them the confidence to partner for all cause ARDS. Unbelievable really. No other data to go on for ARDS except for this small pilot study and the knowledge that the MOA for GVHD is the same for ARDS.

It appears Mesoblast has been stabbed in the back with a well-honed double edged sword.

Well played Novartis.

CHF - sniff sniff.

Pretty plausible IMO