Now-If You Can't Market Your Product For Diabetic Foot Ulcers, Nor Can You Make Claims...
Listen, if you can't market your product for diabetic foot ulcers; and by 'market' it is understood that OSIR is NOT allowed to make any claims as to the stem cell efficacy. They have to go through a NDA. So, given this fact; I think reimbursement will be tough. AND, the FDA WILL be watching this closely. If OSIR tries to report some good revenue numbers in the diabetic foot ulcer segment; this will raise RED FLAGS to the FDA. We will be on this and observing as well. This is about to get interesting....
Let's meet the three losers
Now that we've discussed Shire's opportunities for growth, let's take a look at the three laggards that posted double-digit declines during the third quarter.
Indications Q3 Revenue Growth (YOY) Percentage of Total Revenue Replagal
Fabry disease $108.5 million (11%) 9%
Adderall XR ADHD $81.4 million (20%) 7%
Dermagraft Diabetic foot ulcers $23.9 million (29%) 2%
Sources: Company earnings release, author's calculations.
The market for diabetic foot ulcer treatments is also getting crowded. Shire's Dermagraft competes with Osiris Therapeutics' Grafix and several other competing treatments, all of which use similar stem cell treatments to promote the faster closure of wounds from diabetic foot ulcers.
Me thinks "we" needs an education. It's not a NDA, it's a BLA. FDA agree to grafix regulated as a 361, so "we" is making it up as 'we' goes along. And I can't wait until earnings, they will blow Becky's compression socks off!
You do realize that we shorted(and are still short) ARNA from MUCH higher levels. Please do your homework and check my posts. And, I am NOT a user of ARNA's product. Don't need it. Also, we think it is garbage and that is why we have shorted the stock. It is a dangerous product....