PharmaCyte Biotech Inc (PMCB)

[DragonBear]

Austrianova is currently commissioning a GMP manufacturing facility for ‘Novacaps®’ in anticipation of obtaining Marketing Authorisation for the product in 2009/2010

In another words the CIABs Lohr used were not GMP compliant. Does the FDA require GMP compliancy for a Phase 1/2? Ya bet!

Then they were planning to run a Phase 3 in 2008, under the EMA that would take 1-2 yrs. After that presto instant marketing. Well, at least it's not quite as ridiculous as Kenny's 6 months, and we're "almost there" idea.

BTW - a PC treatment with Fast Track status can take up to 4 yrs in Phase 3. Then again, PMCB doesn't have Fast Track status - does it?

I am sure FDA has already been reviewing

You'll be disappointed to know the FDA doesn't review anything in an IND, until after it's submitted. And QC must be completed first.

The Kenny refiling of a new patient making the same claims as the expired AN patent is bogus. I don't recall "Pepper" being in any Kenny PR pumps.