From my understanding - the FDA don't have a requirement for...

From my understanding - the FDA don't have a requirement for DMOAD. This is an add-in which PAR are doing to drive a higher price-point and/or increase adoption rates and bring it closer to a first-line treatment. I'd assume they could just go straight to EU, but a likely part of the approval would be based on sufficient patient numbers (as a whole) so if you just focus on one which is currently looking to recruit 150 patients (I don't know the number), would now likely become 800 as a standalone study so I don't think there is any huge benefit in doing that. @iken2950 - agreed - dose response should have been done prior to the Ph2b. Mind boggling why it wasn't even looked at before this point. Pills work differently to injections so you can't just take the going-rate for one and know it's the safest viable rate in humans.

What I'll find interesting is what can the team come up with in between now and the AGM to stem the bleeding and likely strike? Given the sentiment around it recently, will anyone believe it anyway? Or everyone can just continue blaming the shorters / JP Morgans like they have for years.