Replies to post #736372 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

You are completely clueless about FDA regulation. Again, the FDA ALLOWS endpoints to change/amend as long as the person who changes the endpoints(drafts a new SAP) is NOT biased from previous SAP/efficacy analysis. In there comes Duffy hired by NWBO.

How does bringing Duffy in help? It is true that he could have been dark on the IA results. But the failure of the PFS endpoint was publicly well known by that time. The JTM paper maid the crystal clear, but the clues were in place with the failure to perform the final analysis as planned, the FDA hold.

The FDA ALLOWS to change endpoints after AI study DoDo look at Anavex they changed the endpoints after datalock and have now submitted MAA.

I don't follow ANVX closely, but I believe the trial endpoint changs was for Rett syndrome and the recent submission was for Alzheimer. Different trials. Not that ANVX would be a poster boy for studies done right anyway.

You were never able to quote the FDA where your rehashed BS statement is confirmed

This is statistics 101. Anything can happen by pure luck in a trial. If you can test one hypothesis after another until one works then every large trial will be a success, ust find the right subset or metric. For certain NWBO knew their first choice failed. Though I cannot prove it, I am certain they knew the second endpoint (OS 232 vs 99) failed. So they went to a third choice.