NINE! Welcome to the action. You are overweight my baby now Crescent Point... Oh how I wish you had just bought with me originally and rode this bad boy... I escaped off and may now look to get back in. Glad you're on board!
Small cap trades are very tough I just got manhandled by CTLP.> I may have an idea for you today.
Did 19 mil vol go the wrong way?
Iovance FDA delay has 'some pretty big silver linings,' says Mizuho » 06:47 IOVA
-U.S. Food and Drug Administration Updates Prescription Drug User Fee Act (PDUFA) Action Date for Lifileucel for the Treatment of Advanced Melanoma
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Iovance Biotherapeutics, Inc. (IOVA)
NasdaqGM - NasdaqGM Real Time Price.
4.6450-0.7900(-14.54%)<---------------
At close: September 14 04:00PM EDT
5.46+0.82(+17.57%)<----------
Pre-Market:-
Taking into account yesterdays sell off on this news we are only up 3% this am....
Iovance Biotherapeutics, Inc.
Priority Review Continues with Successful Facility Inspections Completed,
no Major Review Issues
FDA Extends PDUFA Date to February 24, 2024 on Resource Constraints and Agrees to Work with Iovance to Expedite Remaining Review
SAN CARLOS, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced the U.S. Food and Drug Administration (FDA), because of resource constraints, requires additional time to complete the Priority Review of Iovance’s Biologics License Application (BLA) for lifileucel. The BLA is seeking accelerated approval of lifileucel for patients with advanced melanoma. The FDA extended the new target action date for a decision under the Prescription Drug User Fee Act (PDUFA) to February 24, 2024, but agreed to work with Iovance to expedite the remaining review for a potentially earlier approval date.
The FDA recently notified Iovance that they had insufficient resources to review a recent response to an information request for the ongoing BLA review prior to the planned late-cycle review meeting scheduled for September 11, 2023. In a meeting with the FDA held on September 14, 2023, the FDA acknowledged the resource constraints and agreed to work closely with Iovance to expedite the remaining review.
The overall BLA process continues under Priority Review with several recent positive status updates. The FDA reiterated there are no major review issues, and there are no plans to hold an advisory committee meeting. In addition, all pre-approval inspections of clinical sites. internal and external manufacturing and testing facilities have been successfully completed. The FDA is also engaged and has expressed no concerns on the status of the TILVANCE-301 confirmatory trial in frontline advanced melanoma, which remains on track to be well underway by the PDUFA date.
