Navidea Biopharmaceuticals Inc (NAVB): >> The BLA is open so the review t...

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Re: drbio45 post# 127

Wednesday, 04/21/2004 11:30:02 AM

Wednesday, April 21, 2004 11:30:02 AM

>> The BLA is open so the review time could be from 3 to 6 months from submission of the supplemental data <<

According to the company, it will take a year to enroll 150-200 patients in the confirmatory trial once the trial actually gets underway. Then the patients will have to be followed for at least another year (and perhaps longer) to determine the survival benefit. Add time for data analysis and the FDA review and we are talking about a minimum of three years before RIGS could be approved for marketing with a survival indication.

Regarding the so-called “diagnostic approval” mentioned in the CC, this is merely a hope on NEOP’s part; the FDA has not agreed to entertain approval of RIGS without a survival benefit, although they might still decide to do so.

Moreover, I can’t see RIGS attaining much commercial traction without a survival indication. Several posters have stated that they would surely want RIGS to be used if they had colorectal cancer. I agree with this completely but, emotions aside, you have to look at things from the surgeon’s perspective too.

Surgeons are busy and time is money. Why would a surgeon want to mess with a cumbersome tool involving radioactive materials without an FDA label that going to all this trouble will provide a bona fide survival benefit to the patient?

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