Replies to post #54694 on Avid Bioservices Inc (CDMO)

[MobyInvestor]

Thurly,

Why not go directly to the source? Here's a link to the FDA's regulations for an IND.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312

As I said previously, only phase I requires the evaluation of safety in a new drug, specifically it's pharmacokinetics and pharmacological effects on humans.

The evalution of safety is not required in any clinical trial phase after phase I as evidenced in the 3 of the 5 Peregrine Bavi AC phase II trials that DO NOT have a primary or secondary outcome measure that is flagged as a safety issue, much less even mentioned "safety" at all.

Again, none of the first 3 phase II's mentioned "signal seeking" either.

Regards,

moby