Dr. Richard Pazdur, Director of the FDA’s Oncology Center of Excellence said, "so I think the drug regulation will follow after we have effective therapies and the regulatory hurdles to getting a drug approved will be minimal really if these drugs are truly effective..."
Dr. Ned Sharpless, Director of the National Cancer Institute said, "doesn't look like progress at all until progress arrives, ......
my father died of metastatic melanoma in 2010. The first immunotherapy drug for metastatic melanin was approved in 2011. I can promise you in 2010 things looked pretty bleak for metastatic melanoma and that we has 30 years progress and lots of new therapies and lots of ideas but it didn't really pay off until about 12 months after my dad died so you know and now we cur,e cure, big c make the cancer go away never come back most patients with metastatic melanoma now just a mere less than 10 years later. so when the progress happens it can happen pretty quickly it doesn't look much is happening from the outside until we get there pretty quickly ......"
In the video, it talked about the confirmation of the very heterogeneity nature of GBM which calls for truly personalized approach; no meaningful progresses have been made in treating GBM over the last decades; CI as a class has seen successes in many indications in the past six to seven years particularly, but has shown no effects whatever when it is used in treating GBM in clinical trials.
And I consider it a good thing the discussion has no mentioning of vaccine treatment for obvious reason. And it seems while everyone involved look serious, FDA Pazdur is smiling all the time as if he know something others don't know.
