H-W arithmetic on effective exclusivity period for NCE’s: <pre> 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</pre> 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.