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Biotech / Medical : Nuvelo(NUVO) -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (128)	12/12/2006 6:42:36 PM
From: DewDiligence_on_SI	Respond to of 140

>What do the catheter results say about the drug's ability to dissolve in a timely basis a clot as compared to one embedded in your leg? If it can't do the simple, why expect it to do the hard one?< The answer is that the protocol of the catheter-occlusion trial did not include a step to verify that the occlusion was caused by a clot! Many occlusions are caused by something else—even a kink in the IV line can do it—and Alfimeprase does nothing in those instances. I discussed this trial design at length with NUVO’s IR about a year ago, and I told them that this design was like a batter stepping up to home plate with an 0-1 count. To which IR’s reply was that nurses in the real world do not check IV lines to ascertain the cause of a clot; rather, they administer a clot-lysing agent and wait. If the agent does not lyse the clot within a specified time, they replace the line. Thus, according to IR, the design of the phase-3 trial in catheter occlusion simulated real-world conditions, and this was something the FDA had asked for.