AGM 2024 - QUESTIONS, page-55

Im 7/8 glass full...1/8 empty, specially on this one....why?

Well the gateway to even begin a P3 was a P2....what did we do in our P2? 2x2.
We did it in a well controlled double blinded multi site yeah?







This was accepted and the IND was, (after a number of painful rounds by the FDA) declared open.

It is very unlikely the FDA will make us want to do a separate dosing arm again on the 2x2 ...not impossible, but very unlikely in my personal opinion. We have the clearance of the data to date in both 005 and 008, we have the dosing safety profile for the 2x2. I would suggest PAR would argue vehemently if this was the case if the FDA suggested a sep dosing study on 2x2.

Though I admit at the end of the day we have to listen and do what they say. In the very unlikely chance this would play out like this, I would think EMA could be a sep. route then, while we work out if we de harmonise (I think of it like breaking a database synch mirror).

Yes we should be prepared for hurdles.

PAR have done a number of pre clinical and non clincial studies to rule out the adrenal findings...
PAR has involved onerous screening and patient monitoring most likely utilising such tests as the ACTH test, an onerous one for the patients to ensure cortisol levels are naturally kept to a normal level before the test in the early mornings...

We will have to wait for the green light...let's see.




My views