Cytodyn Inc (CYDY)

[ohm20]

The FDA is in breach of its own guidelines. At the pre-submission meeting it was established that the FDA wanted safety data from 50 more 700mg patients in the monotherapy trial. When the company achieved that the FDA changed its mind and has now done so once again.

As far as re-submitting the application, not necessarily. That's what the type A meeting will determine. If the FDA still refuses to submit Nader should still insist on filing under protest. By the time of that meeting we will have the leverage of publicity and to not file under protest would be negligent on Nader's part.

When discussing the planned submission of these applications at a presubmission meeting, the FDA and the applicant reach agreements regarding the content of a complete application for the proposed indication(s) as well as agreements, if any, on submission of minor components that may be submitted not later than 30 calendar days after submission of the original application. Unless the applicant and the FDA have agreed at the presubmission meeting to delayed submission of certain components of the application, the FDA expects applications to be complete at the time of submission. If agreed-upon delayed minor components are not received within 30 calendar days after receipt of the original application, the application will be considered incomplete. Incomplete applications may be refused for filing. A rolling review permitted under fast track designation has similar obligations.

Within 30 days of the date of the review division’s RTF notification, the applicant may request in writing an informal conference with the FDA to discuss whether the FDA should file the
application.

In general, the review division will grant an informal conference request if submitted within the 30-day time frame described above. If, after the informal conference, the applicant requests that the review division file the application (with or without amendments to correct the deficiencies), the review division will file the application over protest pursuant to § 314.101(a)(3), notify the applicant in writing, and review it as filed. The applicant need not resubmit a copy of an application filed over protest. If an NDA is filed over protest, the filing date will be designated as 60 days after the receipt date of the informal conference meeting request. Applications for NME NDAs or original BLAs received between October 1, 2012, through September 30, 2017, that are filed over protest will not be reviewed under the Program. Alternatively, the applicant may amend the NDA and resubmit it, and the review division will make a separate determination whether the resubmitted NDA may be filed.

https://www.fda.gov/media/109758/download