Senti even the experts are puzzled by this unprecedented type of halt. Don't you think someone as smart as Smith would be able to figure out if this were nothing more than reaching full enrollment? It's much more complicated than that, as you are aware, but I understand your desire to avoid the more negative possibilities.
Let's think about this for a minute. There could be a multitude of issues that would fall under the category of misconduct. Things not even mentioned in the Phase V report. If a regulatory agency said we won't allow you to continue your trials (yes plural) until certain matters are investigated and resolved, how could this be announced without throwing gasoline on the shorts already blazing bonfire? What would it look like?
Well for L, it means no new patients can be screened. Existing patients can continue to receive treatment since they have already had such invasive procedures done. And what about Direct? Well, phase two initiation grinds to a halt just as we have seen.
So how do we move foward? First we need to find some help. Hello Michael Meehan. One of your areas of expertise is crisis management? Perfect, welcome to the team. Okay, so here's the plan. We need to conduct an independent investigation to resolve these matters, but we can't let on that this is required or tied to our trials being halted, or we are toast. Well, why don't we have NW request it? And how fortuitous, there just happens to be an anonymous report to use as a 'reason' to get the ball rolling. Let's set up a face to face with NW in October to discuss.
Okay, so we tell the authority that we are innocent of any wrongdoing and are willing to prove it by initiating the independent investigation. They agree to the plan and say that continuation of the trials will be contingent on the findings in the final report. This could be considered "dialogue, could it not?
Since the company execs fully believe they are innocent of any wrongdoing, they can publicly maintain that they are unaware of anything fundamentally "wrong" (remember it's all baloney) and of course they don't know of any reason (the allegations are all false) why the stock is dropping like a lead balloon (hey I know Les, let's blame the naked shorts).
Anyway, this is just as plausible as any other scenario. Much more so IMO than anything regarding efficacy.
This is what happens with a company doesn't provide any transparency or explanation after everything completely stops for the better part of a year. The sky is the limit when it comes to theories and ideas as to what's going on. Maybe my hypothetical scenario is a million miles off, maybe not.
