"Partial Clinical Hold: A delay or suspension of only part of the clinical work requested under the IND (e.g., a specific protocol or part of a protocol is not allowed to proceed; however, other protocols or parts of the protocol are allowed to proceed under the IND)."
Wasn't there a major focus by the FDA on injectibles contamination lately? I wonder too if maybe NWBO did not implement the new DC mfg method in the US and other trials, where they had patents, perhaps waiting for Germany so that the countries would stay uniform, and any procedures for validation could be debated once by all the agencies, and agreed upon, before starting that validation.
I think LP said they had started using the new DC mfg process for DCVax-L... but maybe that is not exactly what she said. Have to find that language. It was posted yesterday by somebody.
Restated: So... maybe NWBO had not implemented the new sealed DC Mfg process yet, anywhere for DCVax-L, and was waiting for the German patent, when this big FDA focus on injectibles contamination came about, resulting in inspections of all such facilities, and they dug up a problem at Cognate, and the resolve by NWBO was to implement the new sealed Mfg process, but they were waiting for the German patent so that validation could be agreed upon by all parties. Ie, maybe Germany did not want to participate in such a discussion up front because the issue was moot without the patent.
If so, there would be two separate parts to the delay. First the FDA calling a halt either to allow inspections or because of a negative inspection result, then the further delay by NWBO waiting for the German patent to initiate usage of the sealed DC process worldwide.
Yeeeeaaaah, that it! That's the ticket!
Is this what RK or Sentiment, or CherryTree already said?
