Biotech Values

[DewDiligence]

Updated Evizon timeline:

Last June, in #msg-6805766, I had this to say:

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2009 is the best-case scenario [for FDA approval] assuming that GENR’s NDA submission is based on two-year data. If enrollment in the phase-3 trials is slow, 2010 is more likely.

The timeline depends to a great extent on the trial sites that will be set up internationally. Clearly, GENR is emphasizing international recruitment—it will be very difficult to enroll U.S. patients into a placebo-controlled trial…
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GENR’s CEO, Jack Armstrong, conceded as much on today’s CC. However, I no longer think an FDA approval for Evizon as soon as 2009 is achievable. Let’s looks at the details:

1. Assume that the “301” study will be only six months late completing enrollment as Armstrong predicted on today’s CC. That will make the total enrollment time 18 months (June 2005 to Dec 2006).

2. Assume, optimistically, that the “302” study can also be fully enrolled in 18 months. Armstrong said today that “302” will start enrolling in late 2006. I have my doubts that GENR will hold to this guidance (they need to find many suitable clinical sites in the Third World), but for the sake of discussion let’s assume that they meet the late-2006 start date. Then 18 months to enroll the “302” trial will take until 2Q08.

3. Once all patients are enrolled in the “302” trial, one year of treatment will run until 2Q09, and two years of treatment will run until 2Q10.

4. Given the FDA’s newfound emphasis on the safety of drugs that are taken on a long-term basis for non-life-threatening conditions, I think the Agency will want to see the full two years of safety data from the “301” and “302” trials before ruling on the approvability of Evizon. However, for the sake of discussion, let’s assume very optimistically that the FDA agrees to review Evizon based on only one-year of data from each phase-3 trial. In that case, the last piece of data would be available in 2Q09.

5. Allow three months to clean and analyze the database, three months to prepare the NDA, and six months for a priority review. This takes us to a 2Q10 decision and a possible mid-2010 launch.

6. If there is any slippage in the above assumptions—or if the FDA asks to see two-year rather than one-year data—then the earliest launch would be 2011.

No matter how you slice it, Evizon is a long way from hitting the market.