Doc Logic:
Raising hell by patient advocates, friendly oncologists and the general public after a CRL or no-approval decision by the FDA is too late.
NWBO's strategy of silence for fear of upsetting the FDA and possibly compromising a chance for approval all the while allowing the free fall of the share price is completely misplaced. Malevolents like AF have had a field day running rings around two lawyers who should know, and assumedly can do, better. Blaming the share price cratering on naked shorts has worn thin especially after statements from LG that a string of PRs would also include announcing action against such malevolents. Rings hollow and sounds very much like "the dog ate my home work for lunch." When nothing happened and asked WTF is CB doing, LG sheepishly averred that it is not the "right time." NWBO management has not met a timeline they did not miss---and by miles.
I have been a regulatory lawyer and worked with regulatory agencies in the US. These agencies have their own agendas. They will not be "nice" to those whom they regulate, even if they are "nice" and keep silent. It is a sign of weakness especially from a small company. The agency strongly believes it has leverage and the meek regulated party will do nothing and roll-over. I have seen this time and again. Agencies don't want trouble especially from a squeaky wheel. NWBO is a relatively unknown factor because it has been so quiet. It is hardly mentioned in the literature and when it rarely is, the information is either dated or even wrong. The FDA may believe that even if it releases a CRL pending ultimate approval that there will be relatively little or no push back. "Who the hell is NWBO"?
The time to break silence is now and not after a decision by the FDA. IMHO, the strategy of silence has proven to be deadly, not golden.
