Synaptogenix Inc (SNPX)

[Whatsupp]

Yes, oops you were wrong, you stated that the administration method is not part of BE, it clearly is. Also BE does not require rerunning phase 1 or phase 2 and just needs to be part of phase 3. So your point was that the oral method would require starting over that is clearly wrong.

"BE can be waived for an oral solution if the
formulation has the same active ingredient in the same concentration and dosage form as the RLD, and does not contain any excipient that significantly affects drug absorption or availability.17 "

What it says is that if the drug absorption is not effected the BE can be waived, even if it is not waived, the tests are clinical not requiring a long trial.