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Re: Bio_pete post# 52954

Tuesday, 10/09/2007 10:58:31 AM

Tuesday, October 09, 2007 10:58:31 AM

Post# of 253527

PANC- it seems to me the questions are: how the two new liquid formulation will work and whether conducting a phase 3 with a liquid and later with a pill would increase total development costs without a proportional increase in revenues.

The last CC indicated the company conducted phase 1 for two liquid formulations, why results were not disclosed is unclear to me. So the phase 2 will have to be redone to test dosage. This delay can explain the share price, but overall the news is good.
On the total development cost, if they get a liquid formulation approved with two phase 3, could they apply for a 505(b)(2) and conduct a single confirmatory trial for the pill? I would think so..
At least, the company should confirm the statement made in the last CC that a liquid formula would target a different group of patients than the pill. This seems unconfirmed to me, but it might be that bringing the liquid formula to market early could bring revenues or a partner faster..

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