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Biotech / Medical : Biotech News

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From: Gary Mohilner9/5/2008 3:38:06 PM
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Check out the results DNA achieved in breast cancer patients refractory to Herceptin and in some cases Tykerb with T-DM1, here's a link:

www1.investorvillage.com

If this trial concludes the way it's started, the data would be worthy of registration except for one problem, they weren't using Pivotal Quality Material. DNA is starting two new Phase II Trials both announced to be potentially registrational, and a decisions yet to be made on a Phase III.

In my view the two Phase II's could lead to approval faster, so the need for a Phase III is somewhat questionable, but as an IMGN investor it would certainly be nice as IMGN would receive a substantial Milestone Payment. Otherwise it's uncertain when IMGN may collect a payment, though they're owed something in the $30+ million range by approval, then royalties start kicking in and hopefully grow to $100 million or more a year over a few years time. This would require the drug to exceed minimum blockbuster status, but if all trials are successful it should be the replacement for Herceptin in almost all cases, that should make it a blockbuster many times over in a few years after approval.

Gary
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