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Biotech / Medical : ImmunoGen -- Ignore unavailable to you. Want to Upgrade?

To: Chi Wong who wrote (2980)	4/3/2000 2:17:00 PM
From: Gary Mohilner	Read Replies (1) \| Respond to of 5665

Chi, From what I understand the fastest accelerated trial is achieved when citing results the FDA virtually takes over the trial and runs the accelerated Phase 3 themselves. This is not something I'm personally knowledgeable about, but it was mentioned some time ago by a very knowledgeable poster. Having said that, I believe if the word Curative proves to be a proper description of results when they go into the Multi-Dose portion of the Phase 1/2 Trial, I believe that the FDA could take on the Phase 3 on receipt of the results. Remember, you asked the earliest, in that scenario, the FDA could make that decision by this Summer. Phase 1 should conclude between June and September, if Curative describes the results of the Multi-Dose Trial, I could definitely see the FDA saying that the Phase 2 portion of the trial need not be further extended. They could then proceed directly into Phase 3. If we see the Multi-Dose Trial begin this month, using the highest dose currently given in the single dose, three or more months may be required to see Curative results. As the dose is escalated the time frame will hopefully come down. By June the dosage may be up to levels where results are achieved in just over a month. While the protocol may have the trial continuing until negative side effects are seen, I believe if most patients are seeing substantial improvements to complete remissions, the FDA will be eager to get Phase 3 going even as dosage escalation continues in the Phase 1/2 Protocol. Bottom line, I see Phase 3 starting at the earliest by about August, and I'd say the chances of it starting sometime this year are excellent. Everything of course is predicated on the performance of the drug, but from what we've heard, the drug is doing just fine. Gary