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DewDiligence

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DewDiligence

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Re: rph_in_wi post# 3798

Tuesday, 09/28/2004 9:59:35 PM

Tuesday, September 28, 2004 9:59:35 PM

Post# of 257295
Re: Adding the 10mg dose:

>> What does that mean? Was it based on adverse events at the higher doses or did the PK info cause Genaera to feel that the drug's distribution/elimination characteristics enabled a lower dose. The statements' ambiguity causes me to lean towards negative assumptions. <<

You’re absolutely right about the ambiguity –there are always two ways to interpret these kinds of events. In this case, I lean toward the positive interpretation because:

1. Squalamine showed a good safety profile in cancer trials at doses as high as 800mg/day and 4,000mg/week (#msg-3892760)!

2. The 10mg AMD dose was not a bolt from the blue but rather a part of the protocol for the 18-patient PK trial.

--
Where I think GENR may be spinning things is in its contention that adding the 10mg dose to the Visudyne combo trial necessitated a long delay in starting the trial. I don’t buy this; adjusting a phase-2 protocol to add a dose should be a relatively quick and simple process. As stated in my one of my prior posts, I think a shortage of available drug was probably responsible for at least part for he delay in launching the combo trial.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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