Thanks. Not much in 10Q to go on for Regen. Jus
Post# of 5066
Posted On: 08/08/2014 4:22:46 PM
Thanks.
Not much in 10Q to go on for Regen. Just numbers without any indicators we are nearer to anything concrete.
HemaXellerate I only needed "clarification" 3 months ago and still no word on anything other than dCellVax had some success when applied to human cells "similar" to the planned IND application. "Similar", "clarification", "normal part of IND process" - these are all terms that avoid direct response. After the initial IND for HemaXellerate, the normal response to FDA questions and issues has taken over 18 months and we still don't know where it's at, whether it will ever come to fruition or whether the "clarification" of safety studies means we are still years away.
I have a hard time keeping any real hope of actual success being "around the corner" anymore.
Not much in 10Q to go on for Regen. Just numbers without any indicators we are nearer to anything concrete.
HemaXellerate I only needed "clarification" 3 months ago and still no word on anything other than dCellVax had some success when applied to human cells "similar" to the planned IND application. "Similar", "clarification", "normal part of IND process" - these are all terms that avoid direct response. After the initial IND for HemaXellerate, the normal response to FDA questions and issues has taken over 18 months and we still don't know where it's at, whether it will ever come to fruition or whether the "clarification" of safety studies means we are still years away.
I have a hard time keeping any real hope of actual success being "around the corner" anymore.
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