MSB Trading - Aug 2020 on, page-1353

I understand your point but I dont think it is going to both.

Ultimately as I pointed out, the meeting is for that purpose. Surely they dont meet for a few minutes just to hand them the approval. They talk, ask questions and get answers and its not like FDA could not correspond directly and discreetly with MSB about what they want to know or that MSB would be going into this meeting blind folded having no idea where the data pointed.

My point being is, regardless of whether FDA has concerns or not, they can be discussed in the meeting and likelihood is the company knows whats going to be discussed at the meeting as they would be informed and updated during the different parts of the study right?

I think either it is common for the FDA to throw hurdles IF they dont think they are going to approve something, ahead of the meeting rather than in the meeting in the way markets would be made aware of it

OR

They want to approve something but some boxes do need to be ticked and addressed during the meeting so they are giving additional time to the company to get right to the point.