RE:RE:RE:Phase 2 information "Ethical " to shareholders or not.Hempdoc wrote
Enrique wrote:
This is standard procedure. They will not announce results for each patient as no one has ever done so. The DSMB's may decide to present preliminary data at appropriate venues, such as AUA or ASCO etc. given enough data is available to show at least preliminary results. I'm hoping 6-10 patients for AUA meeting in May, but no guarantees,although DR Lilge is giving an update in June on PH1 and PH2 trials. After the IND, and a barrage of trial sites coming on-board we should definitely trend up and get patients treated at a greatly accelerated pace IMO.
Thanks for that input. My only question is...does the preliminary data have to meet statistical significance or at least some minimum statistical threshold before those results should be shared at any type of venue? I think DSMBs are becoming more stringent because of historical precedence & the negative ramifications of sharing a data set that is "too preliminary" (or ultimately invalidated). Even docs can be fallible, & if they were to refer patients to a given trial based on what ultimately were fallacious or statistically insignificant results, that could raise raise not only regulatory eyebrows, but also some judges' gavels....IMO. Though as a shareholder, I will gladly take whatever data they provide...as long as it's positive : )
Good luck...
Where I copied that abstract from was so many variations listed I felt it would confuse this trial being that all examples were for drugs and the compound TDL-1433 in this trial tends to act like a food with no or very little toxics. This leads me to a question " did the FDA also try to treat this as a drug" even though it is classified as a drug but not or is it?