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bill56

01/25/12 12:17 PM

#37475 RE: greens12 #37471

Green . Not sure about a friday PR...But they have "NEWS"...When are they going to release it...I would say prior to sending in the (IND) documents...

Raggoz

01/25/12 12:17 PM

#37476 RE: greens12 #37471

I agree, greens12.

Smilin' Penny Assassin

01/25/12 12:19 PM

#37481 RE: greens12 #37471

I agree with you greens 100%, they feel confident in the biopsy results. This is very huge for CBIS!!

Greenland

01/25/12 12:21 PM

#37483 RE: greens12 #37471

(b) A sponsor shall not begin a clin- ical investigation subject to §312.2(a) until the investigation is subject to an IND which is in effect in accordance with § 312.40.

In my opinion, it will take the required 30 days after applying for the consent, to be able to send the drugs to different locations/ volunteer trials etc. the results have to be part of the FDA process.