Bruce and thread,
I must confess to being somewhat confused amidst the cross-currents of favorable and neutral reactions to the onset and efficacy of levalbuterol compared with the racemic version. At a superficial level, the conclusions of the Medical Letter lend some credence to the hawking management is taking from the FDA in its March and May letters regarding promotional materials, as compared to approved labeling content. On the other hand, JACI and perhaps other journals have reported at least anecdotal evidence of the superiority of overall efficacy/side effects profile of SEPR's ICE.
My question for the thread, particularly Dr. Harmon, the good doctors, Peter and others, is whether there is a tack of analysis to be made in the following query: Was SEPR's Phase II/III protocol designed in such a manner as to ensure recommendation for marketing approval by the advisory committee rather than focusing on efficacy distinctions with the racemic product? One would suspect that focusing on efficacy would normally overwhelmingly lead to the same conclusion on the part of the advisory committee. But, as the trials are sophisticated, planned programs of drug administration to selected patient populations, perhaps the protocol was designed in a way that superiority of the aforesaid profile would not necessarily hit home as the first, ineluctible conclusion implicit in the phase results.
Or am I off the wall? Otherwise, I find it difficult to reconcile the cross-currents here.
Regards. Steven |
