Replies to post #47843 on NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

http://www.biolifesolutions.com/biopreservation-media/Poster_Eyrich_ISCT2013_135.pdf

[Tony888]

The screening halt could have been triggered by a series of bad DCVax batches or something going wrong in the manufacturing process. If NWBO loses the ability to make DCVax, the study would have to halt enrollment but not necessarily halt treatment for patients enrolled previously,

This is from their last 10Q

For the three months ended September 30, 2015 and September 30, 2014, respectively, the Company made net disbursements to Cognate of approximately $7.1 million (with invoices generally being paid all in cash rather than half in cash and half in stock), versus $1.4 million With the substantial expansion of recruitment in the Phase III DCVax-L trial during this period, patient volume has exceeded the maximum amount contracted for, and as a result the disbursements have included excess production costs. In addition, the disbursements have included preparatory work for multiple Phase II clinical trials, as well as development work connected with new intellectual property and certain regulatory requirements. The disbursements have also included substantial one-time services related to manufacturing expansion in Europe.

So you are saying they had production problems and therefore halted screening and at the same time produced more vaccines for more patients than they originally contracted for. Make sense.

[koman]

Adam, can you be more specific in regards to testing for potency for an autologous DC vaccine. How is the DCVAX-L being tested for potency according to the protocol - if you know the specific potency assay that would be helpful.

" Each DCVax product must meet certain potency standards before being released for injection into the patient. " AF

[Tony888]

The screening halt could have been triggered by a series of bad DCVax batches or something going wrong in the manufacturing process. If NWBO loses the ability to make DCVax, the study would have to halt enrollment but not necessarily halt treatment for patients enrolled previously - AF

We can rule this out. As per highlighted in the below company PR, company is submitting information from the trial for regulatory review, not information related to manufacturing for regulatory review.

BETHESDA, MD, August 21, 2015 – Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, confirmed today that its Phase III trial of DCVax®-L for newly diagnosed glioblastoma multiforme (GBM) is ongoing and the patients enrolled in the trial are continuing to be treated per the protocol.

Over 300 patients have been recruited for the trial. The total anticipated enrollment is 348 patients.

The only change in status of the trial is that new screening of patient candidates for the trial has been temporarily suspended while the Company submits certain information from the trial for regulatory review.

Such screening involves the initial evaluation of patient candidates to determine whether they meet eligibility criteria for the trial (e.g., whether they are within the eligible age range, do not have certain viral diseases, etc.)

Some blogs and social media comments have noted that the EudraCT trials database in Europe states that there is a “Temporary Halt” of the trial in Germany. In actuality, the trial status in Germany is that the trial is ongoing as noted above, and the Company has only undertaken a temporary suspension of new screening.

The Company has sought to have the EudraCT listing corrected, but the database includes only certain pre-specified categories and there is no category that corresponds to a temporary suspension of new screening only, while a trial is ongoing.

The Company is in the process of preparing the trial information for regulatory review and anticipates submission within the next couple of weeks.

[notbrad]

That hypothesis is extremely stupid because patients enrolled are continuing to get their treatment.

[sentiment_stocks]

I'm curious to read your explanation as to how the trial enrollment went from 300 in late August (per the PR) to "close to" 348 in December as per Bear Trap's post pertaining to Linda's comments at the share holder's meeting.

If there were "bad DCVax batches", do you think they would have been able to increase the trial size to kinda-just-abou-exactly where they need to be to be fully enrolled these past 3 months?

The screening halt could have been triggered by a series of bad DCVax batches or something going wrong in the manufacturing process. If NWBO loses the ability to make DCVax, the study would have to halt enrollment but not necessarily halt treatment for patients enrolled previously