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Saturday, August 13, 2016 7:33:38 PM
For example the statement in his article:
Since last August, almost one year ago, Northwest Bio has been unable to enroll patients into the study. Without patients to complete enrollment, the DCVax-L study has been effectively shut down for one year.
We all know that is completely untrue. The phase-3 has well over 300 patients enrolled since last August and has continued to treat patients despite the temporary halt in screening new patients. For all any of us know it could have been put in place because all of the patients are living longer with especially with the crossover.
IMHO It makes far more sense to me what Dan88 posted recently:
IMHO, what happened around the partial halt announced last July is that the 1st PFS event counts were reached, the 1st interim analysis was conducted by DMC and the company received the recommendation from DMC.
I guess that the difference of PFS between the two arms may be more than 6 months, so the company might determine to temporarily stop screening for more patients since it might have enough patients for the statistical analysis of both PFS and OS endpoints; the company then might pursue an AA passageway or/and other passageways. Behind the scene, regulatory discussions, negotiations, submissions, FDA comments/hints, etc., have been going on back and forth. Nobody knows what is going on, but definitely something is going on and at some point, something has to be given, or the "issue" will be resolved.
SO the article is not well thought through opinion based on clever investigative reporting, uncovering new facts or piecing complex things together to produce some compelling revelation. It is a distortion of the facts.
Men who are occupied in the restoration of health to other men, by the joint exertion of skill and humanity, are above all the great of the earth. They even partake of divinity, since to preserve and renew is almost as noble as to create.
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