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notshakenorstirred Member Profile
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notshakenorstirred   Thursday, 05/03/18 06:11:44 PM
Re: molee post# 199
Post # of 236 

FDA grants $AQSZF$ a fast track to approval!

Time to increase my 10K position, substantially!

Camargo Pharmaceutical Services
is kicking ass, helping Aequus expedite and navigate the deep waters of the FDA, and all the potential roadblocks...which at this point are rapidly disappearing!

I can't tell you how incredibly important and exciting of a PR this is!!!

"FDA has agreed with Aequus’ proposed clinical plan for AQS1303 which is expected to include only a single clinical efficacy study;"

"FDA has confirmed that an abbreviated 505(b)(2) regulatory pathway would be appropriate for the submission of AQS1303, Aequus’ long-acting anti-nausea patch for nausea and vomiting associated with pregnancy, for approval in the United States"

"FDA has indicated that a bioequivalence study to bridge oral Diclegis® safety and efficacy data with AQS1303 is likely acceptable, reducing the clinical requirements for the program compared to a typical new chemical entity drug submission;"




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