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Friday, August 28, 2015 3:12:18 PM
What happening is DMC's recommendation to the company via CRO halt for efficacy and what is going on is the consultation with FDA, etc, on whether an AA or outright approval is a possibility or whether the trial needs just continue, as the universal or trial-wide halt is now in effect, not only in Germany.
If there is safety concern or actual safety consequence, FDA will immediately place a hold and the company will stop treating patients enrolled in the trial, let alone screening, etc.until investigation into such an issue is complete.
The time for the first interim results and recommendation is just right, and the company has let us in the dark for so long a time; as the price is high, the company has not yet raised any new funds, ... all point to such a happening.
Now the only thing makes me think otherwise, or there must be other something (possibility) up in the air is that the market has not responded the way that an AA is in the process, otherwise the price must have been in the teens or twenties at least!
Either way, as long as safety issue is ruled out, holding or adding some may not be a bad idea!
Never check back my English in most of my board writing, so sorry for any errors or inconvenience!
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