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sunspotter

11/09/10 12:32 PM

#1880 RE: bigtuna177 #1877

"However they have a chance for an "Accelerated approval"......Of course it would depend on the clinical results. IMO"

One off the many signals screaming SCAM!! about Spencer Pharmaceuticals is that there are precisely no clinical results for Met4 (or any other of their alleged pipeline products), and therefore it's simply inconceivable that they could be considered as having an acceptable filing, let alone fast track or accelerated approval.

SPPH know that were they even to submit an NDA to FDA they would get an RTF* within a heartbeat.

* RTF: Refusal to File: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM080561.pdf

And all their PRs and timelines imply they will gain approval for Met4 without testing in humans.

And that's just (factually and ethically) wrong.