Thank you for the link to the Health Canada Special Access Program (SAP). Read through the information and noted the limitations.
In my post, due to the ambiguity of exactly what was granted, I termed it "official (while limited) approval to Cytodyn for the use of Leronlimab with TNBC patients."
Thus you'll note that I did NOT call it an EUA, and after reading the "Special Access Program for Drugs" agree that it's not an EUA but more like a hybrid somewhere between an EIND, an RTT, or a CSP (as in the Philippines). While not an EUA, it will allow Canadians with TNBC the possibility of accessing Leronlimab. It appears CytoDyn must have taken the necessary first steps (as outlined in the link) to make this possible.
The SAP programs sets certain obligations on the Drug's producer for acceptance into the SAP program and it appears those conditions must have been met.
I'm not primarily focused on the income aspect, as much as the accessibility of Leronlimab and am pleased that, providing the necessary paperwork is completed and approvals are granted, Leronlimab can be utilized.
I will also note that Nader Pourhassan Ph. D. DID NOT TERM THIS AN EUA OR FULL OUT APPROVAL FOR USAGE OF THE DRUG.
As I read the SAP information, it also suggests the drug may be used in other appropriate situations providing the necessary paperwork and approval have been completed/approved. This was NOT limited to TNBC, but TNBC was simply the first identified application. This would potentially open the door to other applications of leronlimab in Canada. Ex: if a patient had stage four colon cancer and had run out of options, an SAP could be utilized to access Leronlimab.
Bottom line: If folks are looking at this as a vibrant income producer - they'll be a bit disappointed, BUT The approval for the SAP program opens the door to usage (under the SAP regulations) of Leronlimab in addressing a range of indications in Canada.
That's good!!
Now a final thought - I believe I read somewhere Chris Recknor(?) had identified a test(s) that illuminated the presence/level of CCR5 involved in the indication. If I grasp the idea correctly, the pronounced CCR5 presence suggests Leronlimab would have significant utility in addressing the indication. If the CCR5 is not found to be present then Leronlimab would (probably) not be of value in the treatment. Thus a "package" should include the testing as an initial step to determine the relevance of Leronlimab to the proposed treatment.
IMO
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