>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?
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”