Replies to post #71184 on NorthWest Biotherapeutics Inc (NWBO)

[pgsd]

Results will be coming soon and as tastygreenwafers points out on investor village, they do not have to wait for PFS or OS to end the trial. Meeting the following criteria they will qualify for accelerated approval and as the UK NHS reported in april 06th that is exactly what NWBO was doing

"Apr 16: Northwest Bio plans to apply for fast track status in the US [18].
16/06/2016 09:41:53"


"The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval."

http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4815

[flipper44]

There was a great exchange at a conference presentation by LP many many months ago, and an audience member (sounded like an analyst) asked if top line results or trial completion would occur by summer 2016 (aka: now), and I think LP stated no, no, no or something to that effect (and that it should happen earlier around winter 2015/2016), but then another audience member interrupted and said, unless patients are doing really well, and LP acknowledged that may or may not be true, but these were all just guesses or predictions anyway.

Ah, here it is, I lost my search rights when I went to cheapskate Ihub member, but then I remembered Senti's intro had RK's transcript.

Conference attendee #5: And another question that I had, is that given the timeframe that you sketched for the DCVax-L, it looks like you probably will have data in, let's say in mid-2016? What are you thinking the.

Linda Powers interrupts: No, no, no, no. No, well, if you know if the patients, umm, depending on the patients, of course. No, we think it is more like close to the turn of the year. Like the beginning of 2016, not the middle.

Conference attendee #5: Okay, okay.

Conference attendee #1: that's because the patients are doing well.

Linda Powers: But it's a prediction. Right? Any of these things are not set in stone, whatsoever, and everybody needs to kind of remember that. -- investorshub.advfn.com/NorthWest-Biotherapeutics-NWBO-3441/ December 10, 2014.

OK, I'm off the board again, awaiting results. Sorry for another brief interruption.