The law is in agreement with me, not that there is NO duty, but that the 4 day rule does not apply as people think it applies, and certainly not in this instance. You can talk generically and in your generic chatter make undisclosed assumptions about what you think the law says and argue until you are blue in the face.
Do I think in the case of an unambiguous failure a company would be wise to delay disclosure? No, not a wise move.
Would they be liable, probably not if they went past 4 days, but they’d run into problems in their regular reporting quarterly and annually if they deceived investors. That is what I have always said.
This is NOT that case by far. The blind data makes that patently obvious. There is no instance in my opinion where they could not likely reasonably conclude they have a basis to proceed forward with an application with the FDA and not expect a careful consideration of their application for approval.
So in my opinion, there is no way in hell that rule applies to that situation nor doi think they are running afoul of disclosure rules. All IMHO.
I think the precedent agrees with me. But I am not here to educate you. There is no way that my opinion feeds shorts.
As for the other opinion, I think you just don’t seem to be accepting subtlety as a reality. You want to see it all as black and white. There are complexities to all of this.
I recall being denounced as feeding the shorts when I explained how complicated the prices for updating the SAP with 4 RA’s would be and how long I thought it would take. The best posters thought my suggestions, though I did not give dates, but my suggestions of how complex and long it would be were ridiculous. My experience informed me, not people on bulletin boards who sounded great or had spoken to x, y or z. The reality was, I was correct. It took much longer than the estimates.
I did not say that to suppress the price, but to give an honest opinion. The same is true now. This is exceedingly complicated. I do not for a minute think NWBO is sitting on results or preventing them from being released. They have 3 regulators already to make their publication but obviously having the FDA have the guidance out would make it that much more powerful. When an agency suggests they are going to make something final soon, probably it is still worth waiting for them.
But they can make an executive decision at any time regardless. But I do not think that is what they want to do. That might feed shorts. Your argument about this, while suggesting I am short, feeds them. It makes it seem like NWBO are the ones responsible for the delay. And the shorts make that into, it must have failed or be questionable. That is not my point at all. I do not believe that in any possible circumstance except that the updated policy is a very helpful circumstance to expediting approval ultimately. Probably achieving their hopes for accelerated status and accelerating many other trials and maybe accelerating access to DCVax under the 21st Century Cures Act for any relevant cancers.
So no, I am not feeding shorts.
All IMHO.
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