Thanks needle."Anyway fairly quickly, the person from the FDA...

Thanks needle.

"Anyway fairly quickly, the person from the FDA who spoke first (and following these new July FDA guidelines)......was adamant that prior to FDA allowing future Brain Mets Trials, drug companies must be designing drugs that work outside of the brain also. She advised drug companies " need a plan for outside of the brain" for new Brain Mets Trials.The host, Prof Rohan was definitely taken aback by that. Surprised is one word and maybe not altogether happy another. (just my observation).....he mentioned over the course of the day, other drugs would be targeting just CNS,. ......The KZA CEO said only in recent days, GDC 0084 works in other cancers outside of the Brain, for PI3k mutated cancers. Important stuff, in view of the FDA's new rules."

Making a wild leap forward, perhaps the FDA has just raised the bar, in the knowledge that there is already a drug in the pipeline that meets that dual criteria, and is letting anyone else know that they are wasting their time to not at least match that.