Vorlon, I truly appreciate all your work on this Board, so the following is not directed at you but to PVCT management. I decided to check, too, but with the FDA, not the company. I spoke with a woman in the FDA's "Drug Information" division, and I asked her about the rules surrounding Expanded Access Protocols (same as Compassionate Use). The most interesting takeaways were:
-- Only a patient's Doctor can make an official request for access to a CUP program
-- Only a patient who has no other treatment options AND does not have access to a clinical trial, can qualify for CUP access.
-- IND Sponsor (e.g. PVCT) has sole authority whether to allow patient access to its CUP
-- IND Sponsor has authority to set conditions of CUP access, including, but not limited to, things like inclusion/exclusion criteria, and just what data is to be generated
-- Once a patient is enrolled in CUP, company CAN collect almost any data it so desires with regard to patient's response to the drug.
-- Except for SAE's (Serious Adverse Events -- which MUST be reported to FDA), the FDA does NOT have rules regarding data collection. Companies CAN collect CUP data if they want, and they can also decide to NOT collect data.
-- If data is collected, and again excepting SAEs, the IND Sponsor has the sole authority to decide what to do with that data. It can retain it, publish it, or even bury it if the company chooses to do so. It is all up to the company to decide.
-- the FDA does not give a lot of weight to CUP data, however, because CUP programs are not blinded, randomized, or compared to another therapy (i.e. not as clinically significant as data from a properly constructed clinical trial).
So I think my question stands. If the FDA will let Provectus collect and even publish CUP data, why has Provectus decided NOT to collect or publish its CUP data?
