Provectus Pharmaceuticals Inc., a development-stage oncology and dermatology biopharmaceutical company, today announced it has received guidance from the U.S. Food and Drug Administration (FDA) to submit its phase 3 protocol for review.
This guidance is in response to Provectus’ request for a final end-of-phase 2 meeting regarding consensus of the design of a planned pivotal phase 3 randomized controlled trial (RCT) of PV-10 for metastatic melanoma. In its response, Provectus said the FDA indicated that an additional end-of-phase 2 meeting with Provectus is not required.
Receiving Special Protocol Assessment (SPA) for approval of PV-10 for melanoma indication would represent an agreement from the FDA that the company’s phase 3 study design endpoints, statistical analyses, and other components of the planned clinical trials are acceptable to support approval of the product.
“Following our third meeting with the Agency in October, we believed that significant progress had been achieved in defining the threshold the FDA will require for approval in melanoma, which is a rapidly evolving therapeutic area,” Craig Dees, Ph.D., CEO of Provectus stated in the press release. “Using recommendations of senior FDA officials from that meeting, including those related to patient population and primary endpoint, we intend to request SPA review of our protocol, which we expect will be submitted before the end of the first quarter. While SPA can occur over as little as 45 calendar days, it is important to note that this is frequently an iterative process, and could take longer as we work with the Agency to reach ultimate agreement on study design.”
For more information visit www.pvct.com
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