Biotech Values

[zipjet]

>>I’m unsure whether the FDA is stalling or not ...

That is an interesting question.

Why did the FDA tell MNTA that they needed immunogenicity data? If they were just stalling - they did not have to issue a not approvable letter. They could have just stalled. Perhaps, Sandoz was pushing them for a decision. Perhaps, when pushed they figured they had to give some reason to turn it down and for cover said they were requiring similar data from the other applicants.

If FDA admits that MNTA has satisfied their standard for sameness then Sandoz could sue. The higher the agency sets the immunogenicity data hurdle the greater the chance Sandoz sues.

JMHO

ij