SP,
Here's an article for those who haven't seen the news:
go2net.newsalert.com
I see a couple of things.
My understanding is that the methodology behind the studies of Celebrex for FAP was inferior (they sampled a small part of the colon, whereas polyps are not evenly distributed throughout). Thus approval for Aptosyn should be a slam dunk if it shows similar or better efficacy. Also the large dose of Celebrex required could trigger a COX-1 effect (if I'm remebering my jargon correctly). I believe Aptosyn also demonstrated a better response rate. It's also to be priced more cheaply. All the above from the conference call, notes to which I put up a few posts back. So I think it will be approved and that it will compete well in the marketplace.
That said, I wish they'd gotten out of the starting gate a little sooner. Being second to market behind a big Pharma makes the launch a little tougher unless the drug is significantly better/cheaper. It may mean that Aptosyn sales will ramp more slowly than first anticipated. Watch out for lowered estimates from analysts. I would sell then, if I thought I spotted it before the majority of the market, then buy back in.
Anyhow, FAP is the foot in the door indication for Aptosyn. Upon approval, CLPA will go after bigger markets. With the safety data already garnered, the approval process for these next indications will go much faster and cheaper. To me, this is the real value of the first approval. I do not know if approval will cause the stock to rocket or not, but as the above sinks in, I expect the price to at least steadily reflect it.
Just my HO.
Cheers, Tuck |
