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Re: Biowatch post# 65758

Tuesday, 09/02/2008 3:18:51 PM

Tuesday, September 02, 2008 3:18:51 PM

Post# of 257660
>INGN – The more cynical question is why file [a BLA], knowing they only had a sixty day window before a go/no go decision from the FDA?<

1. It provides an opportunity to raise capital.

2. Against all odds, it might work (like a Hail Mary pass from your own 10-yard line in football).

3. In the extremely likely event of an RTF letter, the company can claim that the FDA is at fault and request a hearing, perpetuating the whole process while the executives continue to earn fat salaries and bonuses.

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A better way to look at this is to ask what would happen if the company announced it would not submit a BLA?

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