Other than rumor, and innuendo, nothing here has changed. Everything we see tells us this is moving
in a positive direction. Nothing else is different than it was three months ago. There might be a bigger
push to get retail to give up their shares, but that's for another discussion. I keep buying on the low
points of the day, and am still convinced this will turn out well.
Bit of a Perfect Storm with the *failed* Primary Endpoint of the NTM Trial coinciding with the Biotech Correction. Dilution is always a concern with Bio's especially depending upon what exactly the FDA says with regards to the NTM situations and increased monthly burn with new hires, infrastructure, etc. as well. But you can't help but think that there will be significant off-label prescriptions from the Euro/Canadian CF indication, though, no matter. Mr. Lewis hasn't said much about off-label Rx because, well, he's not supposed too. Theoretically, even with a PH III NTM trial underway (IF needed), patients outside of a trial might be prescribed Arykace, elsewhere, right?
gee let me guess..Canadian off labels sales... lol . Pullllease stop, Insmed has announced no regulatory pathway a fda decision on the drug and trial status or when or if the co plans to file in the EU...hopefully soon.
The fact is Arikayce is still be trialed in the PH III CF (European) for another 7 months for safety and that looks good as of the 1st year results reported. Also, Arikayce is still (or was still) being administered to other patients after the NTM PH II trial closed in October. Those will not go unnoticed with the EMA and FDA. We will soon know those additional results.
My belief is that if we focus on the current pps, we are missing the big upcoming picture. My theory is that when news comes it will be in avalanche form: one PR after another. As I stated a few weeks ago, I believe that the tutes want all retail out of the picture and that Wedbush might be working behind the scenes to affect this decline. I think that by June 1st we see the pps well into the $20's or higher. Long and not worried.