Replies to post #261888 on NorthWest Biotherapeutics Inc (NWBO)
He acknowledged that the SAP took longer than anticipated but that they are extremely pleased with the outcome.
Ms. Powers continued: “We believe it is now appropriate for the Company to move forward with the
several stages of work that are needed to reach completion of this trial program,
despite the fact that
-- there are good arguments for allowing the data to mature even further.
The upcoming stages include
-- finalizing the Statistical Analysis Plan,
-- conducting the final data collection,
-- data validation and data lock,
-- and then unblinding and analyzing the data.
“Each of these are multi-month processes, and will involve tremendous work by both our team and teams of outside experts.
In addition, virtually all aspects of the Company’s work involve pioneering.
There is no well established pathway, and any projections or predictions are subject to material changes as we go along.”
01/29/20 3:13 AM
01/29/20 6:51 AM
01/29/20 9:16 AM
01/29/20 12:15 PM
He acknowledged that the SAP took longer than anticipated but that they are extremely pleased with the outcome. He sounded extremely confident.
01/29/20 12:31 PM
They want to release "stupendous"(yes, he used that exact word) information all at once and to catch the shorts unaware. NWBO knows who they are and have amassed considerable and compelling evidence. He said releasing piecemeal good news only gives the shorts opportunities to prepare and short.
Les said that we are on the 3 yard line and they are not going to fumble the ball.
Les specifically said that if the FDA follows these guidelines, cross-over is no longer an issue.
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