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Biotech / Medical : CLTR COULTER PHARMACEUTICAL
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To: Gordon James who wrote (454)12/10/1999 12:46:00 PM
From: biowa  Read Replies (2) of 666
 
Gordon,

Thanks for the EXTENSIVE due diligence; we owe you a beer. Heck, as soon as the BLA is accepted we owe you a keg and the St. Bernard to carry it.

I still think the issue of excluding patients from the Zev clinical trials based on the In-dosimetry could be sticky. How do you show safety if you don't treat the very patients you believe would be at risk? The only way IMHO is if you do enough patients w/o having anyone fail the dosimetry that the FDA believes you that NO ONE will fail the dosimetry; and they've already had one equivocal failure (my compliments to them for disclosing that instead of burying it under the fact that the patient wasn't failed using another analysis method). But I've got to assume that their regulatory people have considered that.

Second problem is how do you show that that dosimetry exclusion criteria was the right one? If potentially radiotherapy related side effects are greater than Bex, can you show that they wouldn't have been reduced with dosing by dosimetry? There probably is the math, but its another argument with the FDA.

With these possibilties, I begin to wonder if Zev might not face some regulatory dlays of its own?

In the end, I hope whatever is best for the patient wins out.

As for local radio-labeling, I suspect that some physicians won't mind, others might find it an issue. I hope that's not what the distinction between Bex and Zev comes down to.

Once again, BIG THANKS.
biowa
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