OK mz, CBMI is a biotech company that has a molecule that is used in a medical device. This gets into a grey area. The collagen implant with the OP-1 molecule is treated by the FDA as a medical device, even though you could say that the molecule is a pharmaceutical. By the way, it is generally far easier to get a med device approved than a pharma drug.
<<<<<<
Stryker Corp., said Monday that data from a clinical trial with its OP-1 bone growth agent showed it to be about as effective as a standard bone repair technique in fixing difficult fractures.
The medical technology company added, however, that one set of data from the clinical trial -- which matched OP-1 against standard bone autograft surgery --
did not meet expectations.
In a presentation at the American Academy of Orthopedic Surgeons in New Orleans, Stryker and OP-1 collaborator Creative Biomolecules Inc
said the OP-1 data were presented by Dr. George Muschler of the Cleveland Clinic.
The randomized prospective study included 122 patients at 18 different centers throughout the United States, it said.
''The results demonstrated that the OP-1 Device group had comparable clinical success to the autograft group,'' said Stryker, adding that equivalency could make OP-1 a surgical alternative to autograft because it can reduce pain, infection risk and surgical time and cost.
After surgery, fracture patients treated with OP-1 had reduced pain and were able to bear weight on their repaired bones. But Stryker said follow-up x-ray analysis of the fracture repairs -- for both OP-1 and autograft patients -- did not meet the success target set before the trial began.
''The blinded radiographic assessment by an independent panel of radiologists showed that neither group achieved the predicted level of cortical bridging,''
Stryker said.
>>>>>>>>
The end result is that it is close to being equivalent by these standards, but not quite in all the ways they said it would be. Also, 122 patients seems like a pretty small group to me. My bet is that the FDA asks for more data to be generated. If they are lucky, the FDA will grant conditional approval while they do more clinicals. Personally, I'd love to see it approved and for the FDA to loosen up a bit on these sorts of things, but it's not what I've grown to expect from the FDA.
Rman |
