... janes will you join me in IOVA? If this blows upwards I would feel better knowing others are involved and if it just blows up ,I again would feel better with others in...
A quick summery---
Solid Tumors are the holy grail in Cancer Bio's--> The company's TIL platform has demonstrated broad utility in multiple solid tumors
Co is in talks with the FDA concerning potency assay -some agreement must be made about dosage levels. Discussions are a key regulatory event.
Jan 10-- Iovance appoints Raj Puri as EVP, regulatory strategy, translational medicine 01/10 IOVA Iovance Biotherapeutics announced that Raj K. Puri, M.D., Ph.D., will join the Company as Executive Vice President, Regulatory Strategy and Translational Medicine. Dr. Puri will begin his employment with the Company toward the end of the first quarter of 2022. For more than 19 years, Dr. Puri has served as the director of the Division of Cellular and Gene Therapies in the Office of Tissues and Advanced Therapies at the United States Food and Drug Administration in its Center for Biologics Evaluation and Research. He is also a Chief of Tumor Vaccines and Biotechnology Branch within DCGT.
That's right they hired someone who worked at the FDA for 19 years.... Do I have your attention now? I've been in this game along time....
Last anlyst action 1/28--> Iovance Biotherapeutics upgraded to Buy from Hold at Stifel 01/28 IOVA Stifel analyst Benjamin Burnett upgraded Iovance Biotherapeutics to Buy from Hold with a price target of $25, up from $23. The analyst views the hire of Dr. Raj Puri as a "vote of confidence from someone knowledgeable of the potency assay situation." He now thinks the worst-case scenario is less likely. The two most likely scenarios that could play out from here are: Iovance announces alignment with FDA and files the Biologics License Application as expected, or the company announces there's more potency validation work needed and they push the application, Burnett tells investors in a research note. He's now more optimistic that the application is a matter of when, not if.