I've had a little time to process everything and have a couple of thoughts on the recent events. In the first PR, NWBO stated "The Company is in the process of preparing the trial information for regulatory review and anticipates submission within the next couple of weeks."
For some reason this just isn't what I would expect as a response to a safety issue. Oh hello FDA. What!?? We had a grade V SAE death in the trial? Okay, we’ll get back to you in a few weeks… Yeah, I don’t think so.
Combined with these statements “Those who would try and misrepresent the status of NW Bio's programs are at it again. False impressions have been widely spread today...” (emphasis mine)
What did we hear about nonstop when the screening halt was first announced from our short friends?? Safety and futility. Remember, the only two explanations as to what is going on. I wonder if those two scenarios are the ones address in the “False impressions have been widely spread today” comment. Would they really say that if it were a safety or futility issue? Prudent to consider they have had over 1000 L treatments without a safety issue.
I suppose it would have been easy enough for them to rule out any safety concerns in the PR. However, it would make sense that they are being very careful not to tip their hand on ‘positive’ developments in the trial. My guess is that there are very specific rules and procedures to maintain the trial integrity before or during a regulatory review.
Also, is it possible information from the other L trials could be submitted for AA?
Hoping Larry Smith will weigh in now that he is back from vacation. I always appreciate his perspective and comments.
