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another_voice_2

01/28/14 12:48 PM

#79171 RE: seeker_of_value #79164

This why BT and fast track apps should be sought.

another_voice_2

01/28/14 12:48 PM

#79172 RE: seeker_of_value #79164

This why BT and fast track apps should be sought.

robi-1-kenobi

01/28/14 1:15 PM

#79177 RE: seeker_of_value #79164

Seeker, Accelerated review can be requested in IND submission.

Last I looked at the FDA Guidance, a company can request an accelerated review as early as the IND submission. FluCide could qualify for a few of the 4 accelerated reviews. This allows FDA to provide real-time feedback on the design of the clinical studies. And since you're working directly with FDA, that allows faster review after completion as well (in NDA).

You asked also about multiple animals. From memory, the guidance states data gathering, GLP Tox studies must be done in one small animal species (mice in this case - larger sample size than in the range-finding Tox study) and one large animal species (canines are common - but I think only 3 animals needed). To answer your other question, I believe that the full suite of doses needs to be tested in both species - up to the MFD - max feasible dose. This is the dose at which physical effects not related to drug effect may cause morbidity/mortality. [BTW - they no longer require doses that kill the animals or make them suffer needlessly.]

I need to get back to work after lunch, but you can look up the FDA Guidance Doc for Toxicity Studies on the FDA website using the previous words in this sentence.

P.S. Where FDA says "recommend" in their guidances, they really mean "require".