There is some potential good news regarding the legal letter to...

There is some potential good news regarding the legal letter to the FDA fighting the MSB BLA application of Ryoncil.

The implied threat of the letter is that the FDA will be sued (by Novartis or Incyte or both) if they grant approval for MSBs product for AGHvD for the reasons given in the letter.

If this is the case, then the decision by the FDA was made on legal grounds (threats) rather than medical (efficacy).

Incyte (and Novartis) are simply protecting their current income stream because they must protect their shareholders' interests and their bonuses (sick young kids be damned).

A review of the application and hearing under a new team at the FDA may be in a stronger position now that the threat of legal suit (by Novartis) has been ruled out as they are partnering with MSB. Of course Incyte may continue to pursue the FDA if they approve the 'drug'.

I was wondering if MSB could void the agreement but cannot seem to think of a reason.

They were simply 'out played' by the big boys. The cost of admission in the deep end of the pool is they have give up their left nut so to speak. But once (if) they get approval they get funds for more double blind trials. And they will have learnt a valuable (expensive) lesson...they can't cut any corners, there are no short cuts they will be permitted to take.