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Puffer

10/07/13 7:47 PM

#74854 RE: Nanotoday #74852

The tox tests announced today will not bring the cides to market any faster.



This is an incorrect characterization. As I understand it, data gleaned from the non-GLP studies will allow them to expedite the GLP studies.
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ZincFinger

10/07/13 8:52 PM

#74855 RE: Nanotoday #74852

OVERALL the CTs should go FASTER because of the low toxicity.

It may take a few extra weeks at the start for extra animal tests (to determine the appropriate dose for the animal tests. Say WHAT?! You do widely spaced tests across a very broad range of doses so you can "bracket in" the range to focus on with small increments. A few short tests can make the dose selection of the final tests so much better that they take fewer steps. (Similar to artillery fire: the first volley is in broad steps to get the target "bracketed", then the next volley is small steps within the two previous steps on each side so that all the second volley is very close and the third volley, if necessary, hits it.)

Because with very low toxicity the therapeutic dose will be much less than the toxic dose and the initial dose can be a lot closer to the therapeutic dose than with the usual toxicity **AND** the steps between increments of the doses can be larger = fewer steps = less time. [color=red] Those effects combined speed up the overall process much more than the few extra animal steps slowed it down: OVERALL with low toxicity the trials go faster. [/color]PLUS the odds of success are much better because you can get a therapeutic dose well within the range expected to be effective rather than just barely within it as you sometimes have to settle for.


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noretreat

10/08/13 5:54 AM

#74870 RE: Nanotoday #74852

Hello Nanotoday....

(When I initially made the claim, I NEVER imagined that they would be announcing a interim tox step).



In the past, there have been many times that NNVC has found ways to slice baby steps into tiny pieces and then PR the pieces. Look at all the steps surrounding the cGMP....multiple PR's about financing it and Innohaven, then the architect, then the team of architects, then the engineer, then the custodian, etc. Now there is a search going on for equipment. It gets ridiculous.

The point is that an interim tox step is absolutely no surprise.