Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

I am ashamed to admit, that I, too, have never been present at FDA meeting (hopefully banishment from this board does not follow this revelation). But I have this despicable old-fashioned habit of reading. Hence, over the years I have gone thru, about 50, maybe more, FDA drug acceptance packages and probably dozen or so advisory board meeting prep-materials plus transcripts. In normal times Brilacidin might end up in advisory board meeting. FDA tends to do that with first approval of a drug with novel MOA. I don't see it happening now.

Written submission is not just company sending completed application and FDA reading it and then saying either yay or nay. If you read some of the administrative actions included in approval packages you will notice that FDA will ask additional data, clarifications, object to certain wording and claims and so fort. Sometimes they even launch an investigation of their own. And that starts at pharmacological review. Leo can't answers to any queries, hired trial runners to those pertaining only to trial itself. DeGrado is able to answer to pharmacology and microbiology questions. Those are on his field of expertise.

As to DeGrado being at meetings. Only if necessary.

I recommend reading material available in FDA approval packages and especially FDA advisory board materials. It is mostly boring going but sometimes it can be educational, hilarious (some geezers at advisory boards) and even infuriating (FDA 'political' agenda shining thru). Yes, politics and personal dislikes are involved, occasionally.