NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

its a true statement and for the following reason.

It would be of a tremendous utmost extreme stupidity to lock the database without discussing with the FDA their stands on endpoints change. If the FDA advises to do some parts of the amended SAP differently than then that is very difficult to adhere to after the database has been locked already.

Second. Despite as what others (ex) may tell you. Its no big deal to change endpoints / adjust SAP with the FDA prior to datalock. The only rule the FDA will impose is the employees/staff involved in the SAP adjustment must be objective.
Go ahead and Google FDA policy towards endpoint change/ SAP adjustment prior to data lock. You will notice it is as I described.

Third. Its well known that any biotech with any meaningful clinical trial are in regular discourse with the FDA especially when it comes to SAP adjustment. If the FDA would have advised against the change IMO that is a material event ans must be disclosed