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Biotech / Medical : Biotech vs. Shorts
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To: Gordon James who wrote (207)8/31/1999 3:35:00 PM
From: RWReeves  Read Replies (2) of 427
 
Today's BioWorld gave the following details, mostly quoted, attributed to Bigham:

1. "...requesting easier database access..." (Is that the PC/Mac issue?)

2. "..a computer glitch: one descriptor fell off"

3. "..a reorganization of the analysis.."

4. "...in one section they wanted a different way of looking at the data.."

5. "..in another section they wanted more radiographs and images on non-critical organs"

That was all the detail I could extract from the quoted sections. Bigham said the filing was 55 boxes worth and said most of the work would be reformatting the data and "making sure everything is in sync". He did not say "My dog ate all or part of the filing" as has been widely rumored.

IMO this does not warrant kicking the filing back. The FDA obviously went through the filing in some detail to come up with issues like the additional radiographs.

Most of the stuff listed seems like it could be answered by discussions with the reviewer(s) and supplemental answers. So they must have felt they could not make a decision based on what they had which lead to the refusal to file. I think it was a tough call for them which is why they waited the whole 60 days to make it. Usually you get your "refusal to file" as soon as the FDA can stop laughing long enough to send it. Not the case here.

CBER wants some biologics successes and Bexxar is likely to be a biggie for them which will be widely shown off.

Odd that CLTR didn't anticipate this and provide hard copy of all electronic data, call the reviewers themselves to see if they had any questions or problems with the database or square this with the FDA in the pre-IND/pre BLA meetings. Monday morning quarterbacking? No, been there, done that myself.

As I said in a previous post, it's a real spanking for the RA people and this mistake has cost them (and us) a few hundred million bucks.

Still, agree with everything Prudential and others have said- Bexxar works, it's effective and likely to become a front line therapy. An unfortunate buying opportunity that is likely to last for a while.

RWR

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