An early-stage biotechnology firm, CytoDyn Inc. (OTC.QB: CYDY), recently announced the FDA provided guidance to modify its Phase 3 study and add an open-label extension to the patients meeting the inclusion/exclusion criteria of CD12.
On Monday, December 28, 2020, the FDA will receive a revised CD12 protocol that will include an open-label extension to the regulatory arms. If approved, each clinical site participating in CD12 can enroll additional patients, all of whom will receive leronlimab. Patients who are qualified to participate will continue to receive treatment until the trial’s final results become unblinded.
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The FDA also gave specific guidance for the benefit of physicians pursuing eIND for patients with COVID-19 who must first meet the inclusion/exclusion requirements of the CD12 review. These criteria will be provided in the form of a checklist.
Mahboob Rahman, M.D., Ph.D. the company’s Chief Scientific Officer and Head of Clinical Development, has stated, “We are pleased that the FDA has offered a partial approval of leronlimab which will allow a specific group of patients accesses to the drug, while the Phase 3 study results are awaiting. With the support of the FDA and health care providers, we hope to improve COVID patient outcomes.”
At the previous close, CytoDyn Inc. (OTC.QB: CYDY) rose 7.78% to $5.68. The stock went up to $6.15 simultaneously while its lowest single-day price was $5.40. In the last 52 week period, its price fluctuated between 0.62 and 10.01. At the moment, CYDY market cap is 3,372,458,400, and its last-week performance was recorded 7.88%.