I'm bit split on if this is good or bad news for MSB. It...

I'm bit split on if this is good or bad news for MSB. It effectively takes the key decision out of the hands of the experts and into the hands of 1 man's opinion. Based on the article above, looks like approval was based on "might work", so nothing to lose where no other treatment exists. Did not even indicate a AA with post approval trials / evidence.

We have been there before, 9-1 then rejection.

This makes it feel like the FDA is still not functioning correctly. Approvals should be based on very strong evidence on effectiveness of treatments.

This approach might help us get past the post for the first approval if there are any doubts. However, I would have hoped have we have got the evidence to gain the support of expert panels and approval without help from the boss. Including very clear evidence on long term survival over a number of years. Still leaves it open to the final opinion of Peter Marks !

Does the approach above also reduce the MSB technical moat, lowering the proof levels required by our competitors for diseases with no viable treatment options? MSB has spend years dotting every I and crossing every t to get to the point of being close to approval. Last thing we need is competitors requiring a lower burden of proof to gain approval. Let them be held to the same standards.