Friday, December 09, 2016 1:47:32 AM
The DMC recommended am early halt to the study based on observed efficacy, as early as last year.
Linda refused to accept the recommendation. She has previously gone on record that she wanted the trial to go to completion. Various reasons on why she may want to do this have been discussed here in the past.
DMC shares information with the FDA, or FDA maybe asked for information from the DMC (remember the "extensive regulatory filings" sentence in their 10Q) ?
FDA decided to wait till required events have occurred. If 248 events have occurred of late, then the FDA probably already has this information.
I believe that the next announcement that we get from the company is that DCVax-L has been approved (isn't there a precedence for this, as posted by someone several months ago?). No need for top line, bottom line, data analysis, formal filing for approval.
Just another opinion. Go ahead and bash me - fire away :)
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