Wednesday, June 08, 2016 3:01:55 PM
OK, let's assume what you wrote is correct, which i don't think is true, but for argument's sake, let's make that assumption.
Then why hasn't BASi been able to receive enough material from NNVC to complete Tox on the existing Flucide formula?
Even at 200g batches (that supposedly have been verified) they could have made Kg's by now.
As far as your why not comment. Supposedly material is at a premium. Sparing any for erroneous and non-crucial events seems like they aren't exactly as laser focused as they have claimed (a claim alway proceeded by a change of focus btw).
The so new and unique was in reference to any of the 'cides. Remember, we've been told that because the cides are SO new and SO revolutionary that the FDA will be putting extra scrutiny on all testing and results. My point was that based on this point that the company has made, and understanding how the FDA works, there is little likelihood that the Tox for Flucide 1 would in anyway be admissible for Flucide 2. If they're not the same ECAXT formula, something this NEW and UNIQUE will require it's own complete Tox.
Why would the FDA want to see the data for a prior version of a drug that is not the actual drug being submitted for IND, when the drug being sub,fitted for IND would require all the necessary test results?
Prototypes are rarely considered when the final working version is available.
Oh, wait, I know why none of this seems important...because NNVC is different, the normal rules and laws and commonly accepted procedures and requirements don't apply.
Silly me!
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