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Posted On: 06/28/2019 9:40:58 AM
Post# of 150190
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Re: ClosetInvestor #4396
Yes, it has been a quiet week and still no injection. While I anxiously await injection like others, I realize that this is out of CytoDyn's control now and no longer fault NP or RP for the delay since the Cali site opened about 6 weeks ago. I do wish we would get news about the other sites being opened (I think pending ERB approval still?) to help the trial move faster once it actually begins. I check the clinical trial site almost daily to see when it is updated for these other sites to show they are recruiting.
While it likely wouldn't be very satisfying at the time, maybe NP should not state specific dates outside of his control any more (i.e. for the TNBC delay only project dates to have everything they need to submit for a location to open and state the typical time for ERB review and approval and then typical time expected for recruitment, testing and injection). Or if nothing else explain in more detail all the unexpected work required that caused the initial delay. I know he briefly mentioned the reason in a recent interview and took full responsibility, so for me that was satisfactory enough for the time being. I know they are breaking new ground and paving the way for our future cancer MOA trial. I don't believe this was a rookie mistake or oversight by RP, but more so new requirements with new paperwork / legal things required by the FDA or clinical sites.
While it likely wouldn't be very satisfying at the time, maybe NP should not state specific dates outside of his control any more (i.e. for the TNBC delay only project dates to have everything they need to submit for a location to open and state the typical time for ERB review and approval and then typical time expected for recruitment, testing and injection). Or if nothing else explain in more detail all the unexpected work required that caused the initial delay. I know he briefly mentioned the reason in a recent interview and took full responsibility, so for me that was satisfactory enough for the time being. I know they are breaking new ground and paving the way for our future cancer MOA trial. I don't believe this was a rookie mistake or oversight by RP, but more so new requirements with new paperwork / legal things required by the FDA or clinical sites.
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