Sunday, April 22, 2018 4:12:37 PM
Wrong. Kenny told you, the FDA specifically required this data. One starts with Kenny pumping a CT is just around the corner for years. Instead, currently the FDA is requiring pre-clinical data. This is data that could have, and should have been generated 2 yrs ago. With a stable line of cells already established. What it shows is Kenny has really stretched out his nonsense for years.
As per my previous posts, the FDA would want to know the enzyme kinetics of the cells. Or measurement of pro-drug conversion over time. Note, Kenny provides no data specifics, and no graphs of the results. What levels of Ifosfamide were tested in vitro, and were the enzyme kinetics for each level constant over time? It's something the FDA would look for in the still mythical IND. Quite possible the FDA will want in vivo animal testing to test conversion rate, plus/minus CIAB. IF the mythical IND was ever filed, and granted, the FDA will want to see conversion rates of Ifosfamide measured in a Phase 1 CT plus/minus CIAB.
Other than Ifosfamide's neurotoxicity, neutropenia, and other effects? We'll assume Mensa would be administered to protect the bladder.
Which is what I've been posting for weeks. Where targeted therapy will be combined with chemo as a front line treatment, using front line drugs such as nab-paclitaxel+ gemcitabine. There is no interest in combining them with metronomic doses of monotherapy Ifosfamide, or any other alkylating drug.
Also while Kenny is stuck in pre-clinical, giving his SHs blow by blow pumps, the world of Pancreatic CTs is not standing still. Whether it be a PD-1, P13K, CTGF, or other inhibitor, one has the FDA giving CTs accelerated status, and NDAs accelerated approval.
By the time Kenny ever submits the mythical IND (IF he ever does), the pharma/biotech industry will be into 2nd gen targeted therapy treatments. Current front line Chemo will be second, and 3rd line. Metronomic monotherapy with an alkylating drug will have no place in the treatment of PC.
The Jewel of the Mind is Colored with the Hue of what it Imagines
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