banter and General Discussion, page-10054

End of the quarter no?

Should be an announcement about a BLA resubmission then, no?

I'm assuming no announcement is no resubmission yet as previously they have been announced when they've happened - but also previously they've been rescheduled later as well.

I read some links around one of LearningEachDays posts that gave me some background on a case within the FDA where one of the higher-ups Janet Woodcroft or Woodford or something overruled the principal investigators and an ODAC panel to grant a approval for a product in muscular dytrophy I think.

Only way I see the FDA saying what MSB alleges they've said especially as Silviu is reported to have said is if the FDA has similarly had internal over-ruling of scientists like Matt Klinker.

I think MSB is in a bubble (share price wise) and Cynata is (irrationally) bubbling along with it. If the FDA grants a BLA on the weak evidence MSB has provided I think it will harm the field (cell medicines) and the FDA will have a made a mess - succumbing to politicking and patient advocacy groups (perhaps they really have swayed Peter Marks - but they shouldn't have been able to on - not on the evidence MSB has put up).

MSB should have done an adult trial as the FDA were previously, sensibly, suggesting if not stating they should. I don't know if Peter Marks or others have the FDA have folded - its possible - but I hope not.

I do want MSB to get a BLA when they deserve to get it - but not before. If they get it before and without deserving it it will make for very bad policy and everyone coming afterwards will have to work around very bad policy. Which will slow down the delivery of affordable cell medicines.

Shareholders might cheer about the moats they've erected around themselves and then discover they'll die ahead of the medicines that they might have lived to see had the moats not been there.