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Saturday, August 22, 2015 1:36:03 AM
the Company has only undertaken a temporary suspension of new screening.
I'm reading this to mean that it's the "company" has initiated the temporary suspension of screening; therefore it is not initiated by the regulators.
Also..
The Company is in the process of preparing the trial information for regulatory review and anticipates submission within the next couple of weeks.
It doesn't say anywhere that the company is preparing trial information "requested" by regulators.
Keeping in mind that we were expecting the first IA anytime around the June-August period, it most likely could have something to do with that. If it was a recommendation to stop for futility, the entire trial would be stopped. Remember, the company is in a cash-crunch. That could be a reason for the screening suspension, to halt further expenditures pending feedback from regulators.
In addition, looking at LG's email reply posted by Diamondjim,
Those who would try and misrepresent the status of NW Bio's programs are at it again. False impressions have been widely spread today, in an apparently orchestrated fashion, that our Phase III trial has been stopped. That is not the case.
And..
The only change is that new screening of patient candidates is temporarily suspended while we submit certain trial information for regulatory review.
Why would LG be so emphatic in his words? Here too, it says that while "we" submit; doesn't say info requested by regulators.
LG ends by saying "Please stay tuned". I wouldn't use those words if something dire was happening behind the scene.
Also, keep in mind that this is a PR responding to attacks in "blogs and social media". Maybe I'm reading too much into the wording, but under the circumstances I'm pretty sure that wording has been sufficiently parsed and reviewed by the company.
However, I'm a bit puzzled by why the company would even mention the 300 recruited figure. They could have just mentioned that the trial is still on track to complete enrollment by end of year. Any thoughts on this?
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