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Angry Goat

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Angry Goat

Re: Sage7243 post# 118484

Tuesday, 03/18/2014 12:10:20 PM

Tuesday, March 18, 2014 12:10:20 PM

Post# of 158400
Incorrect.

The paperwork for FDA IND approval to start clinical trials has been submitted. This was submitted ~ 1 year ago. The company is hoping to get Orphan status to expedite its testing and get it to market faster than the normal route assuming the procedure works in humans (it has never been tested in humans, only rats.)

The FDA alerted the company ~ 6 months ago it needed further tests before approving. The company has performed those test but it is not clear if the data has been submitted to the FDA for re-inspection.

So, we wait to see if the FDA actually approves HemaXellerate 1 for IND/Orphan status. That is what will either make or break this company.
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