Unlikely though the theory has been around for a long long time as those without shares by their own words were eagerly pointing this out as a possibility, and after some time "a fact", and happy to repeat at any moment they have had, contradicting an apparent flaw: if an interim analysis, if it were conducted at all, showed no effect in terms of PFS for whatever the reason, and the DMC thought it would be futile to complete the trial, it might recommend the company stop the trial. While the FDA might be notified, it was non of the business of FDA if the company wanted to continue the trial since patients would not be harmed and they were continually receiving the standard of care; FDA has even had no business to impose a partial hold for the company to screen any new patients;
On the other hand, if the vaccine seemed to speed up PFS events due to reasons known or unknown, such as pseudo progressions, only logic is for the FDA to order the company to stop the trial because patients in the trial were harmed. That meant the company had had to stop administrate any vaccines to any patients pending on the company to conduct investigation which could show that reason was false. Then, the FDA might allow the company to continue to administrate vaccines. It was in essence a safety problem. In such case, the trial had to be stopped while investigation initiated aiming to approve otherwise.
We know that was not the case,
In addition, it would put the company in a position of intentionally lied when it had said twice that it had not been aware of any company-wide news or events that could explain the sudden drop of share price in a significant magnitude.
Adding on top of that is Neil Woodford November 2015 multi-ten million dollar financing deal with the company at $5.5 per share, and his now famous words "nothing untoward" in regards to company's situation at that time.
So I don't believe PFS theory at interim has any truth. Instead, I kind of believe that one or two AF like minded investigators in the trial might report to FDA about some presumably irregularities of the trial, such as record keeping, manufacturing changes thus agent changes, suspicious screening criteria for earlier and later patients, etc., considering the trial had been up and down in a period of more than 10 years. The investigator(s) might be recruited by AF or the kind, or they might be just rebellion for unknown reason.
Anyhow, FDA for whatever the reason believed it was for the best interests of patients and the cause to impose a partial halt so that the company could not recruit any more new patients, so that the company might consider to start a new trial from scratch. But the company thought otherwise, and had always believe it had the winning hand: it can at end show FDA how patients treated with DCVax-L live longer, much longer than placebo patients even they later all crossed to being treated with DCVax-L, let alone the norm, including Novocure's (NVCR) Optune therapy device.
After a long back and forth between FDA and company, FDA lifted the halt last Feb, suggesting the dispute or discord has been fully resolved since then.
So I do feel the awkward position for the company in regards to whether such information (the reason for the halt) shall be released or not.
For the integrity of the trial, the company decided it better not disclose the reason until the trial integrity concern becomes no concern. That I would think is when final data are announced, or the company can choose never disclose it, and it is perfectly fine and legal.
BTW, my current sentiment for the stock is strong buy.
[this is my one post a day restriction imposed by IHUB admin and my lack of enthusiasm of posting more]
