Monday, October 21, 2019 4:15:59 PM
The theme for today is Phase 1&2 under the auspices of the EMA is good enough
No GMP for the CIABs Lohr used - the FDA surely doesn't care. Surely the FDA allows P1&P2 CTs to be carried out everyday with non-compliant GMP product???
Also one is suppose to ask the FDA: Do you really really require data from non-IND approved foreign CTs to be compliant, or held to the same standard of FDA IND CTs? Duh. LOL
Who needs to have a P2 requiring 100+ patients. If the EMA thought 13 was good enough in 1999 the FDA won't care now. In fact the FDA won't care the dosage of Ifosfamide, or CIABs were variable in 8 of the 13. The FDA won't care if an arm in a study is variable. And even if they did, again, who needs 100+ patients when N=5 will do for a P2. Statistical analysis works great with a N=5 population.
Then there's the usual theme the whole biotech industry is watching in apprehension as Kenny watches the cells grow. Along with the idea that since TF wants to increase its Asian market, for their lab tissue culture media, that means they just have to buy AN, and then fund PMCB. Seems a strange way for TF to expand into the China market.
IMO Kenny deserves a raise.
The Jewel of the Mind is Colored with the Hue of what it Imagines
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