Replies to post #136117 on PharmaCyte Biotech Inc (PMCB)

[thenewmixer]

Hellooooo? 3 day after IND was filed they say Questions & days later it was place on hold

[A2Z]

Oooh....we were spoon fed the reason this took so long that company had to make sure everything was perfect.

Hmmmm guess that excuse too was hype

Bottom line... this dog still can’t hunt

[DragonBear]

Hellooooo? -FDA isn't asking for anything currently

They made a decision to place the IND on Hold. The "asking" was over after the 30 day IND submission period ended.

The most likely reason for the Hold remains that the Lohr studies do not support jumping straight into a Phase 2b. Either they "asked" previously for data that didn't exist, due to the structure of the studies, and/or concluded the studies were faulty. Nothing more to "ask" there.

Another primary reason is they reviewed the past failed results of using Ifosfamide in 2nd line patients, at Metronomic doses, and concluded there was no evidence it would work as part of the Kenny Wonder Treatment. Nothing more to "ask".

we dont yet know what they are asking for..

SHs don't. But Kenny does. Again "asking" does not equate to reasons for the Hold.

or maybe FDA needs more time to absorb what is already there...

Well, here's a newsflash... there's not much for the FDA to absorb. The Kenny Wonder Treatment is simplistic in concept and content. And they don't need to study Kenny PR pumps, or look at videos on the PMCB website...jeez!