The reason for the nagging question regarding the hold of screening may be simply the FDA's question about whether the trial had been an Adequate and well-controlled (AWC) trial raised in Summer 2015, after "once again" change in screening conditions in Germany, thus the hold of new screening.
The subsequent actions, behaviors of the company, namely and mainly no communications (abnormally quiet, non responsive, etc.) and the company's stubbornness and desires to impress FDA with a "super good" results, particularly OS all explain that is the cause for the hold.
Kind of a marking process based on general multiple items, the company scored poorly early and it wants to make it up in late, which I believe is a success, evidenced by FDA's nod to the removal of the hold late 2016 (of course technically, why not since the company said it would not seek full enrollment, but it did mean FDA has been receptive of the trial since then).
For the reason above, the company could/can not say the reason, fearing it will crash the stock price and most importantly the confidence of patients, investigator, all other involved in the trail about the future of the trial, thus it may potentially ruin the odds of an ultimate successful trial.
Now, it is also no need to reveal why the hold, because the stock price has been crashed, and the data may finally, truly and practically around the corner.
As long as the company is confident it will have a remarkable which should be much better than safe and some efficacy on par with Optune (much better than Optune), it will end the trial and let the process go and release the data.
Now it may be waiting for that decision, and/or its continual communications with FDA. At this later stage with this mature data point, FDA must communicate back to the company on its chance for a successful approval if the results of the trial are like _________.
The current nagging question for a share holder is the company needs more funds to sustain its trial, service its debt, etc., but at a one or two dimes per share, and the strong suggestion of PFS and OS results. It may be well worthy of a buy.
It seems the only possibility the trial will fail is that the control arm patients behave unexpectedly well, a total contrary to what IMUC, Optune, and other similar trials have reveled.
[this is my only post and unedited; take what is worth in your own risk]
