The additional testing might well affect competitive products that are inhaled, such as ARDM's or Aerogen's. EMIS, with its oral formulation, probably will not be affected.
Pfizer claims to have known that the patients in question had pre-existing fibrosis, but I doubt it. My understanding is they didn't say so until it was over. A pharma experienced in bringing drugs through trials should know better than to mix up the data like that intentionally.
ARDM's liquid formulation may get around these problems, actually. My personal feeling is that they have the best pulmonary insulin product, but perhaps not the best business sense, at least from a shareholder's perspective.
Those that were following a little more closely than I was, likely inferred that the additional delay was coming. That INHL's CEO didn't allow for the possibility of filing in '03 (versus 2H02) less than a couple of weeks ago (per an audio clip I just listened to) is bordering on irresponsibility. But that's what safe harbor boilerplate is for, I guess.
No, the delay hurts, period. While the regulatory path may also get tougher for ARDM and Aerogen, that's not a certainty, particularly with the former. And again, EMIS' position just improves. All the stocks have been priced appropriately now, IMVHO.
Cheers, Tuck |
