Replies to post #110018 on Avid Bioservices Inc (CDMO)

[Robert C Jonson]

Due to the excellent safety and if the other ph II trials show strong support, if the FDA had any gonads they would still give bavi AA with a large ph III to back it up.

Geo, I haven't heard AA ruled out (except by Dew) and I still think it's on the table.

[cjgaddy]

Cappy, look at all the Ph.2 AA examples in my post from 7-2012 - many single-arm trials. I don’t know how to check this, but I just don’t think that many generated Stat-Sig, based on low N-values and esp. single-arm designs. I honestly don’t remember seeing that Stag-Sig. as a pre-requisite for AA. AA is by def. Ph2-data-based, right? What % of Ph2’s gen. stat-sig? Plus, stat-sig. doesn’t exist for single-arm trials, does it? ‘Hep me, somebody smart…

Another point: AA is based on Ph2 data - they always require followup confirmatory Ph3 trials to be run. Correct me if I'm wrong.

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7-16-12: Peregrine's Ambitious Goal for Bavi: Accelerated Approval after Phase II: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=77966275