ex arent you happy NWBOs SAP buy-in by the FDA has now finally been resolved?
All we know for a fact is that the FDA did not send LL the notice that the IND change would be placed on hold because of patient safety concerns. Like duh.
That is separate from what the FDA might provide NWBO as an opinion on the changes. This would be sent to NWBO only.
If LL was commenting on the opinion then you have a prima-facia REG-FD violation. If she was only commenting on the lack of a hold, it means nothing.
Pick you poison. Either NWBO is violating SEC laws, or the LL statement means squat.
You have no idea that they submitted an updated SAP. They could have just submitted a protocol modification for the endpoint change. Part of the procedure for changing the trial endpoint is changing the clinical trial registry record. How's that going?
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