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T_T23

02/22/13 8:35 AM

#38397 RE: T_T23 #38396

In addition BMSN can commence the human clinical trial after 30 days if they haven't been contact by the FDA that there are some concern that need to be addressed or they can commence it immediately within the 30 days if the FDA indicates that they are able to. They can also contact BMSN any time immediately and say they need more details/research regarding their IND. So technically, they don't approve or deny IND.
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Skelly22

02/22/13 8:42 AM

#38399 RE: T_T23 #38396

I wouldn't expect a PR saying FDA approves / denies anything. Instead it should say Regen Biopharma initiates Phase I Clinical Trials.