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Naamplao

02/18/17 7:16 PM

#2644 RE: 123414 #2641

This IS NOT what is said in that document.

You are obviously challenged when it comes to reading.... Here it is again

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The study will consist of 2 phases. In the first phase, 3 subjects will receive PDT employing 0.35 mg/cm^2 (maximum recommended starting dose) TLD1433 and 90 J/cm^2 of green light delivered by TLC-3200. If treatment with the maximum recommended starting dose does not raise significant safety concerns as determined by the safety monitoring committee, an additional 6 subjects will receive PDT with 0.70 mg/cm^2 (therapeutic dose) TLD1433 and 90 J/cm^2 of green light delivered by TLC-3200.
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The bolding is mine to make the pertinent lines easier for you to read.

This is not a sound bite of an interview... IT IS THE PROTOCOL FOR THE ACTUAL STUDY.

Clearly they are stating the first dose is NOT the therapeutic dose.. they would be foolish to try the higher dosage first without knowing it would be safe for humans at a lower level. It is 50% less than what their first guess of a therapeutic dose will be. They want to make sure there is no Safety issue in that dose before giving the higher dose which they believe will be a therapeutic dose but that is the hope as the drug is untested on humans.

Will they collect efficacy data on the starting dose... of course they will since it would be compared to the second test dose... BUT it is not the primary focus of this phase of testing, that being safety/tolerance... that is what Phase 2 is all about.