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Replies to #87563 on Biotech Values
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DewDiligence

12/15/09 9:26 PM

#87576 RE: mcbio #87563

ACHN:

I'm curious how the mean 5-day log drop of 3.94 log10 compares to telaprevir and the other PIs. There is no way to do an apples-to-apples comparison I assume as most of the other HCV PIs measured their initial PoC potency data at 3 days I believe.

If I recall correctly, the FDA’s 3-day limit on monotherapy testing was not yet in effect when Telaprevir was in phase-1b; hence, there may be some Telaprevir data we can use for comparison purposes. I’ll do some checking and you can too.
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DewDiligence

12/15/09 9:30 PM

#87577 RE: mcbio #87563

ACHN:

…viral load remained suppressed for at least 7 days after dosing was completed. Isn't it normal for viral loads to quickly rebound in these studies? If so, I presume that this is potentially a good differentiating characteristic for ACH-1625.

The obvious question is: To what extent were viral loads suppressed 7 days after the cessation of dosing (i.e. 12 days into the study)? The mere use of the word suppressed does not tell us much.