Aquestive Therapeutics Inc (NASDAQ: AQST) announced today the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Libervant™ Buccal Film. The new submission was to administer attack bunches to answer the FDA’s September 25, 2020, Complete Response Letter. The proposal comprised added algebraically exhibiting and backup studies of the current scientific data based on the Agency’s direction.
The company received a CRL from the FDA in September 2020
“We believe that the resubmission delivers all of the matters raised in the CRL founded upon the leadership we expected from the FDA,” remarked Keith Kendall, Chief Executive Officer of Aquestive.
Aquestive expected a CRL from the FDA in September 2020, accomplished a Type A conference with the FDA in November 2020, and acknowledged additional leadership from the FDA in February 2021. The company forestalls a six-month appraisal procedure and imagines receiving a PDUFA objective date in late 2021.
Aquestive appoints A. Ernest Toth, Jr as Chief Financial Officer
Aquestive today announced that A. Ernest Toth, Jr., a veteran monetary official and presently serving the company as the temporary Chief Financial Officer, has transitioned to the enduring role of Senior Vice President and Chief Financial Officer active instantly.
Ernie Toth joined Aquestive as Temporary CFO in December 2020 finished the facilities of Danforth Advisors, a referring business providing investment support and planned advisory facilities to life science businesses and the healthcare technology industry.
Before entering Aquestive, Mr. Toth was CFO of EHE Health, nationwide preventive health, primary care, and telehealth system retained by Summit Partners and DW Healthcare Partners.
From January 2016 to December 2016, Mr. Toth was Chief Financial Officer of ArisGlobal, an end-to-end drug growth platform. From January 2015 to December 2015, he functioned as Global Chief Financial Officer of Synowledge.
As CFO, Mr. Toth delivered monetary and working headship through 9 new invention presentations, 17 ANDA filings, a BARDA prize, scientific hearings, and the deal to Warburg Pincus in 2012. From 2014 until its sale to an intended purchaser in 2017, Mr. Toth was a participant of the Board of Directors of Eska, a foremost Canadian brew business owned by Morgan Stanley Private Investments.