NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Hank, my presumption would be that NWBO initiated discussions with the FDA to discuss how to proceed.

Hypothetically:

. NWBO informs FDA of decision, and asserts they plan to continue trial to test the OS endpoint.

. The FDA says that it is OK to continue the trial, but you can not sign up patients with a statement that PFS is being tested when it really now OS being tested.

. NWBO spends a year plus arguing with the FDA on how to solve the issue, then simply terminates enrollment 17 short.

As far as other trials, I can not really think of any other than CellSci. In most cases, the IA is designed to be after enrollment is complete, so this issue would not often come up.

In the CellSci (CVN) case, here are the clift notes from the 10-K (pages 6/7)

. 2014 safety issues raised by IDMC with a rec for full shutdown, but resolved by CVN and IDMC subsequently gave a green light.

. spring 2016 IDMC recommends partial hold to new enrollments.

. 6/2016 CVN responds to IDMC and notifies FDA.

. 8/2016 CVN announces they are expanding the trial size because events slowed down

. 9/2016 FDA issues partial hold on enrollments only, treatment for existing patients continues.

We do not know exactly what the issues were. CVN asserts the safety issues had been resolved, the FDA stated the reasons were:
. Failure to promptly report to the FDA the IDMC recs.
. Failure to disclose to investigators
. A trial that can not meet its goals.

Regardless of the extent to which this matches NWBO, it does show that the sponsor would be expected to report and IDMC finding to the FDA.