Zosano Pharma Requests Type A Meeting with the FDA to Review Resubmission Plans for Qtrypta™ New Drug Application
The purpose of the Type A meeting is to receive FDA input on the requirements for the resubmission of the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA) following the Complete Response Letter (CRL) received on
“We have been working diligently to prepare the meeting package required at the time a Type A meeting request is submitted to FDA. We are sharply focused on the resubmission of the NDA for Qtrypta and have been preparing strategies to address the comments received,” said
The FDA typically responds to a sponsor’s request for a Type A meeting, if granted, with a meeting scheduled within 30 days from the receipt of the request.
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the company’s plan to have a Type A meeting with the FDA and the company’s expectations with respect to the timing of the meeting with the FDA. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause the company’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the company’s business in general, see the most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the
Chief Financial Officer
Source: Zosano Pharma Corporation