regulatory of the FDA or TGA, do we really know exactly what criteria they work by, there are so many clauses sub clauses.
Differing medication, devices, off the shelve etc all have varied pathways to approval.
The would also be special circumstances like an epidemic. FDA certainly allow vaccines through - but under emergency use..... none to my knowledge are fully approved, it might be a cause that under their current guidelines they not really fully approviable. If some recall at least one big pharma put forward incorrect data- trying to fudge the data.
If anyone on here is/or has worked for the TGA any has any thought of the real process pls let us know.
Many are knocking Viraleze in that no human trials; think i read where lab result maybe enough, somewhere in there -think it was from Script that human trails ie blind studies would be problematic.
so what do we really know about the approval process.
Does SPL management think that putting a product forward for approval is a dead end process, is/was never going to get through.
In sighting the WHO recognised animal lab tests... did that approach mean that other products have actually been approved based on WHO recommendations.... quoting WHO, would leave them open to a huge rebutal for WHO if not true. ...image front page new if they took task with SPL ...that would really be a downer.... but then again WHO was ignored when the FDA approved a big pharma product in the earlier treatment in covid.. .it didn't really work in severe case, and said to be harmful to some too, WHO trial was with 40,000 people but ignored.... basically said it did''t work.
Any WHO...Combine that, with the Lab results, safety trial, the active ingredient already approved in other products around the world (actual FDA approved through all their requirements except ??); what else in there.
Maybe is just in the wording of Viraleze that some take offence.
But look at all the vitamin pill etc that all make claims... of everything under the sun... just by using ''may''.
We don't know the real process to approval, it may depend on whether deciding member had their early morning cuppa, I'm use they make mistakes too.
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