My new theory regarding temporary half of screening for new patients, which is not contradictory to my earlier FDA hijacking theory but definitely a lot simpler:
The company, knowing that one major problem which may compromise trial is that the pseudo progression patients are potentially regarded as true progression patients, particularly the mesenchymal subtype of patients (referred to Prins and LL's related papers and videos).
As a result, it voluntarily stopped new patient screening at a time it thought those patients already in the pipeline were enough to get it over to the targeted 348 patient enrolments while submitting information to regulatory agencies (simply referred to FDA below as representative of all three involved agencies). The information submitted contains way to resolve this issue, and asking retrospections of all suspicious cases.
FDA agreed and asked the company to remain at the partial screening halt until further notice after receiving the request and information from the company – now the trial is fully under the control of FDA (an alternative to the hijacking theory).
Dialog has been ongoing back and forth between the company and FDA. On the one hand, FDA may want to make sure the method proposed by the company is indeed trustworthy, scientifically and empirically based (to have a kind of a small trial within the trial to see there is statistically significance so that it can validate the method proposed by the company). This takes lots of time, so six to seven months have passed.
Recently, FDA may have had some data and observed the correlations in which the company has long believed are with merit. It would then ask the company for some further information. As a result, I highly suspect that the company has so far submitted all the relevant information (such as biological assays of all the related or suspected patients before and after the partial halt) to the FDA.
FDA could be in the final validating process now. If it is persuaded, all PFS events will be recounted, which is strongly in the company's favor; if it is not persuaded, anything will be determined as it stands today, or according to the protocol.
I strongly believe and hope FDA will take a scientific, rational and reasonable stance and let the data have the final say.
In the meantime, the 1st and/or 2nd interim analysis events may have been reached, and the analyses may have been conducted with definite analysis data.
Please allow me to conclude with this: It is either $1.xx or $30. You choose, and most importantly, God bless patients to have an effective treatment, and those who believe!
AI
