Replies to post #529371 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It was not a hold, it was a partial hold, which is very different. And it was not for safety reasons, the end result being they were short placebo patients, and placebo patients, by being denied immediate access to DCVax-L, lived demonstrably less time even though upon recurrence, they lived longer than other patients that had recurred. Delaying access was detrimental to their longevity and unnecessary if having crossed over placebo patients ends up creating a trial with no placebo arm anyway.

[LearningEveryTrade]

"PIII trial is on partial clinical hold for screening of new patients for further enrolment"
"patients already in the trial have continued to be treated in accordance with the trial protocol, without interruption"

"FDA lifts the partial clinical hold on PIII trial."
"There is also some possibility that changes requested by the FDA and/or other regulators could complicate the application process for product approval "
"FDA lifts the partial clinical hold on PIII trial."
"The FDA action clears a regulatory concern for Northwest Bio."

Whatever the reason, game was put back on by the FDA, a long time ago.

[Dr Bala]

Totally nonsensical post.

[Doc logic]

HyGro,

The hold is easy to figure out. All remaining treatment patients were enrolled AFTER the screening hold was put in place. That’s the first clue. Randomization did not change but those who had been assigned/randomized to SOC/placebo were obviously kept out of the trial after the hold. That’s the second clue. How do we know this? The hold began at about 300 patients already enrolled so a typically well balanced enrollment process somehow got tremendously skewed with the last 31-32 patients enrolled with the proof being found in the missing 17 SOC/placebo patients, reported at a much later date but suspected early on. This is backed up by what was posted on this forum by way of a shared interaction between a German patient’s wife and her husband’s doctor who hinted that her husband had been assigned to SOC/placebo but would not be enrolled. In what was shared she also asked when the treatment might be available and the doctor expected it around 2020. This is when Covid hit hard but also when the artisan method and perhaps Microden, precursor to Edens, would have been ready. It was also the typical time for when unblinding to NWBO finally would have occurred.
Regulators, and perhaps NWBO, likely determined a link between survival and pseudoprogressors during a safety check and look at the 2015 BLINDED Spring Refresh data. Without NWBO technically having the ability to “know” from unblinding what needed to be done (because without unblinding there is no way to “know” what expected demand might be) this left the company in no man’s land until that issue could be resolved. This also likely put regulators in a situation where they had to be ethically involved, especially in Germany where the last patients were being enrolled and where knowingly subjecting patients to a lesser treatment regimen is not permitted. Hence the screening hold. Fraunhofer stated it as enrolling to the point statistically necessary. Very interesting!; ).
The delays from Covid and likely need for a “bigger boat” (data indicating SOC for rGBM and GBM should be considered when anticipating demand) surely became confirmed at unblinding of data to NWBO based on how data has been presented to date and which is when the massive ramp up by Cognate and CRL likely began in earnest with next level manufacturing, represented by Edens, seeming to be being waited on even while supply chain issues were being worked around by modifications to that manufacturing upgrade. Pretty amazing stuff and always glad to share. Best wishes.