Replies to post #1430 on SurModics Inc (SRDX)

[bridgeofsighs]

Re: I-Vation
Interesting how Barclay said they have had success delivering everything from the I-Vation platform.

[DewDiligence]

>Treated as drugs, not devices? Perhaps this is because the device is easily removable?<

There’s not much logic here on the FDA’s part; for instance, Restylane from MRX is regulated as a device even though the only device that’s part of a Restylane treatment is the syringe used to inject it.

>I hope this would accelerate the review process.<

The point Barclay was trying to make on the CC was that MRK already has a good working relationship with the DAIOP group at the FDA and this will presumably help in mapping out the clinical program for I-vation.

[DewDiligence]

Enrollment complete in phase-3 Medidur DME trial:

http://biz.yahoo.com/prnews/071008/aqm071.html?.v=24

>I wonder whether Medidur is also treated as a drug by the FDA?<

I can’t find any evidence to the contrary, so I assume that it is.