Zosano Pharma Corporation (NASDAQ:ZSAN) has announced the reception of a discipline review letter from the FDA regarding Qtrypta™ 505(b)(2) New Drug Application. The FDA uses the DRL in conveying initial comments in deficiencies that have been established during NDA review relative to a specific review discipline.
FDA highlights two issues in Zosano’s NDA submission for Qtrypta™
The DRL that Zosano received described two issues concerning the clinical pharmacology part of the filed NDA. First, the FDA had concerns with the unexpected high zolmitriptan plasma concentrations observed in 5 study participants from the two pharmacokinetics studies. The FDA also had an issue about how data from the participants will affect the whole clinical pharmacology section of the NDA. The second issue that the FDA identified was about the differences in zolmitriptan exposures witnessed between the participants that received different Qtrypta™ lots in the clinical trials.
It, however, important to note that despite the DRL reflecting initial comments, which are likely to change, it nonetheless doesn’t reflect the final decision of the FDA on the NDA. The Prescription Drug User Fee Act goal date for Qtrypta™ is October 20, 2020, considering the letter’s date.
Zosano focused on the NDA review process despite disappointing FDA response
Steven Lo, the CEO and President of Zosano stated that they are disappointed with the notification but are in the processing of assessing and addressing the FDA’s comments. According to Lo, Qtrypta™ represents a potential therapeutic option for patients that experience migraines, and the company is collaborating with the FDA to ensure the NDA review process is effortless.
Zosano is in storing financial position at the end of September; it had around $43.4 million in cash and investments. The cash position is preliminary and could change the following completion of customary financial statements and review procedures at the end of the quarter. Therefore this provisional information reflects Zosano’s initial estimates with respect to available information and could vary from the actual cash and cash equivalents reported as of September 29. 2020.