Consider this about trials and what has been done over the past 3X years.
We recognize that the FDA has organized an extraordinary set of process steps, which when completed in the proper sequence can be used as evidence of ...exactly that...only...the process was completed as planned. The process steps by themselves are just that a process. BTW, at certain key steps in the sequence a group of previously agreed to experts sit in a room and vote on if and how the process steps were followed and then what happened? (example, yes the process steps were followed exactly and the results suck, now what do we do?). Well so what it sucks, do you want to keep going, after all we either keep going or we tell the world we screwed up to start with and never should have even started b/c the science was weak. The point is of course that the process does not produce shit unless the science is any good. This is how people worked for 30+ years and only proved they were on the wrong path. That should never happen.
Dr.M. has (IMO) seen this as it is , it's a process sequence and he is a play by the rules guy. He follows the process and does new things involving the new Precision medicine detailed/data driven flawless steps which seem to answer questions that have never even been asked. (like what happens if we put Actigraph sleep monitors on all our patients which will provide instantaneous (to the 5th decimal point) data on the sleep patterns(included as evaluation criteria based on science) or our A2-73 trial patients? Cool, and so it goes. More detailed information and quality insights then ever imagined being seen and evaluated using AI reasoning tools at the speed of light producing overwhelming amounts of highest quality information that tells a story never before seen or heard. Does this new data enable a real time leaning process which compiles and grows every minute of the day? Sure it does, that is why we did it...way the hell out in front of the curve.
So, Dr M and staff have transformed the trial process into a scientific verification of the treatments' efficacy system at the speed of light. Huh, you mean then there is really no reason to get the FDA team of experts back in a room so they can look at the data and vote on the truth??? This then means the trial is not a trial in the old sense. The trial is a process verification step in the sequence which allows fact based and inspired decisions to be made w/confidence levels approaching certainty. IMO. This is what is going on and we are blessed to witness it. Stand by b/c it will take a while to see if this is all true. Remember trails by themselves prove nothing if the science is flawed, as we have seen for a long, long time.
AI
