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Re: JakeJ post# 8752

Tuesday, 09/27/2016 7:33:39 AM

Tuesday, September 27, 2016 7:33:39 AM

Post# of 43747
IMO - you are essentially correct here JakeJ.

The change from 10% to 6.5% needs explanation, probably also for the FDA.

6.5% difference is still good but the FDA will need to see current results to back it up.


My guess - CVM didn't follow correct procedures to make the FDA happy - and the FDA has 'dinged' them to get a chance to review what data there is and to get a specific set of explanations as to what CVM is attempting to do here.

It is worth it to note that the FDA didn't stop the trial outright, and is allowing enrolled patients to continue treatments and follow-up assessment.

Also is interesting IMO to note that the announcement indicates ~926 patients currently in the study population,.... so enrollment isn't slowing down post hitting '880'.

The share prices are undoubtedly going to take a hit today though,... it looks worse than it is but it does look bad.

“The two most powerful warriors are patience and time.”
- Leo Nikolaevich Tolstoy

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