Replies to post #87804 on NorthWest Biotherapeutics Inc (NWBO)

[Savage39]

That would be great, and wouldn't surprise me. As nothing has gone as planned with this stock. But in the last paragraph of the PR today it specifically talks about "data lock" and analyzing data which takes months.

What I find odd is where it states "to date, the regulators have not agreed to move the partial clinical hold".

I'm not pretending to have a clue about anything involving the science, but I am having trouble understanding what could be causing that long of a hold. My only conclusion is that it involves other regulators from different countries.

[john1045]

notbrad, I agree and was my thought on this as well as LP had stated she wanted the trail to go to completion. NWBO likes to provide key words in PR's and below in bold and underlined I believe in just another hint that regulators did not want patients continuing into randomization in the Phase III trial as LP stated "turning good news into bad".

From yesterday's PR

However, at this point the Company believes that the potential benefits that could be obtained from enrolling the final 17 patients would not be worth the time it would take, as the process of re-starting and re-training the sites (including through Institutional Review Board renewals) for further enrollment would take months, followed by further months for the recruitment itself.

notbrad:

I still tend to believe in the following possibility (previously espoused by Sentiment):

The DMC recommended am early halt to the study based on observed efficacy, as early as last year.

Linda refused to accept the recommendation. She has previously gone on record that she wanted the trial to go to completion. Various reasons on why she may want to do this have been discussed here in the past.

DMC shares information with the FDA, or FDA maybe asked for information from the DMC (remember the "extensive regulatory filings" sentence in their 10Q) ?

FDA decided to wait till required events have occurred. If 248 events have occurred of late, then the FDA probably already has this information.

I believe that the next announcement that we get from the company is that DCVax-L has been approved (isn't there a precedence for this, as posted by someone several months ago?). No need for top line, bottom line, data analysis, formal filing for approval.

Just another opinion. Go ahead and bash me - fire away :)