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Alias Born 01/07/2009

Re: None

Monday, 09/01/2014 10:58:41 AM

Monday, September 01, 2014 10:58:41 AM

Post# of 158400
The great thing about the market not being open today is that this POS has no chance of going down again.

Someone should labor to get Koos removed as CEO and put someone in there that knows how to run a biotech and submit proper INDs. It is an absolute joke that it is taking them this long to actually get Hemaxellerate approved. It has almost been 18 months.

Investigational New Drug Application (IND): The pharmaceutical company files an IND with the FDA to begin testing the drug in people. The IND becomes effective if the FDA does not disapprove it within 30 days. The IND must include the following information: the results of previous experiments; how, where and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in the animal studies; and how the compound is manufactured. The IND must also be reviewed and approved by the Institutional Review Board where the studies will be conducted.

http://www.medicinenet.com/script/main/art.asp?articlekey=9877

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