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Replies to #74280 on Biotech Values
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DewDiligence

03/11/09 10:10 PM

#74281 RE: Biopharm investor #74280

H-W arithmetic on effective exclusivity period for NCE’s:
 
4.0 yrs to earliest generic application (statutory NCE period less 1 yr)
+ 2.5 yrs (automatic stay on final FDA approval)
=========
6.5 yrs

+0.5 yrs if pediatric extension applies
=========
7.0 yrs total effective period of exclusivity

In other words, BIO and GPhA are still far apart, but not as far apart as the news reports make it seem.

p.s. I know you know all this, but some readers may not.