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dr_lowenstein

02/03/16 11:13 PM

#182145 RE: captainsjg #182144

Naz doesn't care about fda. He already told them that they cannot stop tiny elite. Lol lol
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Dr_Thorfin

02/04/16 12:52 AM

#182165 RE: captainsjg #182144

As long as the outcome is positive, its all good no matter who they please

Phase 3 pivotal trial met its primary endpoint (p = 0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group. Secondary endpoint results were consistent with primary findings and included safety measures.
This positive PHASE 3 trial was a milestone for the company.
From now on its just formality/paperwork wich will take lots of time due to bureaucracy, they can slow us down, BUT THEY CAN NOT STOP US !!!!!!
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Couch

02/04/16 6:10 AM

#182175 RE: captainsjg #182144

I'm not wrong on this couch.


Got it so no proof that Elite requires additional FDA trials. Yeah I am the one who is right here. Next