Momenta Pharmaceuticals, Inc. (MNTA)

[Boing x 2]

DewDiligence,

I agree.

A couple of thoughts,

I think this is critical wording to avoid the games of sales reps telling the doctors to write a script DAW {drawn as written) to keep competition away.

"57 351(k)(4) of the PHS Act, means that “the biological product may be substituted for the

58 reference product without the intervention of the health care provider who prescribed the

59 reference product.”6

"134 An interchangeable product may be substituted for the reference product without the intervention

135 of the health care provider who prescribed the reference product "


I have seen comments by sales reps doing that exact thing and joking about it on line. Keeping sales away from us by telling the doctor’s to write the script DAW so the pharmacist can’t change it.

I would get the patent to cover either way of injection. Doesn’t mean you have to do it but, it would keep others from saying well they didn’t cover auto injector. Amphastar comes to mind on an end around.


"A sponsor developing an

654 interchangeable product generally should not seek licensure for a presentation for which the

655 reference product is not licensed. For example, if the reference product is only marketed in a

656 vial and a prefilled syringe, a sponsor should not seek licensure for the proposed interchangeable

657 product for a different presentation, such as an auto-injector."


Boing X 2