Followers | 10 |
Posts | 2656 |
Boards Moderated | 1 |
Alias Born | 03/05/2018 |
Thursday, May 03, 2018 6:11:44 PM
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;"
http://www.aequuspharma.ca/en/index.htm
https://camargopharma.com/
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM