Friday, April 19, 2019 1:00:30 PM
You don't produce material for a mythical CT, and then after the fact, produce an "operation manual" defining the production steps. cGMP doesn't work backwards. Kenny gets a PASS.
Same could be said back in 2011. PASS
In that case no need for these CTs is there? And whatever the current delay all was worked out back in 2014. So no problems. Or did they lose the "operation manual"? PASS
The only thing the canine study confirm is that massive tumor lysis can occur when treating with a chemo drug, the cancer has never seen before. That those dogs with the heaviest tumor load, shoved into the control group (stacking the deck) did not respond as well. No objective follow up was performed. There was no benefit for survival shown.
Oh the many applications: 1. Unproven for PC, and unable to get past a stalled mythical IND. 2. The FDA requiring any implanted cells for diabetes can be readily extracted. No current way to do that for CIAB. 3. THC cures cancer? Yeah right. What prior CT proved that?
If it's so revolutionary why isn't it going against front line therapy for PC? It's not that expensive with limited number of patients in a Phase 1 CT.
There is no improved CIAB. No new patents for manufacturing an improved CIAB. Austrianova's new patent was for BIAB. Where the BIAB inside membrane dissolves releasing probiotic bacteria or whatever they put inside. Not exactly CIAB is it?
Ooooh multiple doses. Try to find in the 10K the exact protocol proposed - including when these multiple Metronomic Ifosfamide treatments are to be given. And how will they overcome chemo resistance? Low dose will invite it. Unlike the Loeb study which accepted newly diagnosed patients, this one would have patients in the 2nd line, likely to have a well developed stroma around it. How will the Metronomic Ifosfamide metabolized, get into the tumor?
Having better imaging doesn't treat cancers.
No it won't. If the mythical IND ever got submitted, and cash like bat guano fell from the sky to finance it, and if any Oncologist wanting to engage in malpractice recommended enrollment, it would fail.
The Jewel of the Mind is Colored with the Hue of what it Imagines
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