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Biotech / Medical : Biotech Valuation

CRSP 56.61

-0.6%

Nov 6 3:59 PM EST

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To: Biomaven who wrote (7533)	12/18/2002 11:45:57 AM
From: Vector1	Read Replies (2) of 52153

Thanks Peter. The meeting was illuminating as to the reason for the long delay. I think there were four reasons: 1. The FDA became uncomfortable with the original trial design which did not have a control group but rather the patients own records on prior chemo regiments. Unfotunately they were in a box because one of their own committees approved the design. I think the result was a lot of consternation and discussion and a view that the data submitted on prior regimes had to be very very good. 2. The origingal package submitted by Coulter was massively deficient. One FDA reviewer said that there was missing data in ovver 90% of the case files. Even though many of the omissions might have been minor the FDA was already concerned about the lack of a control group. The FDA ultimately required two independant panels to review aspects of the data. When you read through the FDA safety analysis it is clear they took a negative view on any potential area of ambiguity. 3. According to the FDA the sponsor changed manufacturers twice creating concern about whether all patients were in effect getting the same drug. Combine this with the fact that a radioconjugated MAB was novel at the time this gave the FDA fits. They pointed out that they are currentlly not finished with the manufacturing review but made it clear that the lines of communication are much better with CRXA than they had been with Coulter and they did not see this as a major stumbling block. 4. According to the FDA the acquisition of Coulter by CRXA caused some delay. I don't buy this one. The FDA has made it clear that Coulter was a major problem that has been improved by CRXA. Listening to the FDA folks at the panel it is seems to mean they are earnest people trying to do what they think is best. I think the problem is that culturally they are focussed on finding issues not ways to solve them. A young aggressive company in Coulter that had an inexperienced team doing the trials did a lot of damage. What is clear, and the FDA heard this loud and clear is that this drug should be approved ASAP. It is the only compound to result in long term CRs in multiple refractory patients. The committee members (mostly practicing oncologists) were particulary interested in the followup studies inlcuding: Bex v Zev with a safety endpoint powered to show lack of inferiority. Bex v. Rit Bex in front line with long term follow up. One other note. I was quite impressed and moved by the 6 survivors who spoke to the panel. They were strong, intelligent and articulate advocates for the drug. One made the point that most NHL patients become highly educated on treatment options and care deeply about quality of life. God bless these people and may their remissions continue indefinitely. V1

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