Some here have asked for my opinion regarding the current partial clinical hold status of the L trial. It goes something like this..
IMO, the biggest clues come from Dr. Marnix Bosch and Dr. Linda Liau.
1. With regard to the primary end point of PFS: "Pseudo progression wreaks havoc with trials" -Dr. Bosch. It is my opinion that the 1st IA has occurred and the PFS analysis did not predict a likely chance of reaching statistical significance..
Then we have another clue from Dr. Liau.
2. With regard to the secondary end point of OS. "it seems like everyone’s living longer than we would be expecting" -Dr. Liau
If it were not for #2., this trial would likely already be dead in the water IMO. Instead everyone is left scratching their heads trying to figure out how to move forward and deal with the confounding issues surrounding OS, etc., since there seems to be a survival benefit from the treatment. Thus the 6 month delay from the 1st IA. I have a feeling the final conclusion might be to go back to the drawing board and initiate a new phase 3 trial.
With regard to Linda Powers. She is focused on trying to figure out if a certain number of investors became aware of the confidential 1st IA results before anyone else (remember the 30% intra-day drop?) and profited by shorting it down to our current levels. It would be very interesting to know if any sensitive information was communicated or "leaked" around that time. I wonder if anyone (or any group) of investors had a spontaneous "bad feeling" about the stock around that time?? Anyway, it would explain bringing on the CIA investigator specializing in the area of cyber intelligence. But like everything else, who knows..
