Word I'm getting is September on Abbo and I trust my source. Also, you can't just expand the label on D2E7 immediately. You have to go through trials just as if it's a new drug. These trials are beginning this year, but it will be months and years before the label expansions will be approved by FDA. Doesn't stop physicians from using off label, but I think they are reluctant to do this because of legal issues. If you get sued and have been using a drug off label, it gives the vultures more ammunition.
<<If you get sued and have been using a drug off label, it gives the vultures more ammunition.>>
You are partially right here. If there has been a published study, not necessarily approved mind you, this can mitigate legal actions in a number of cases. If it is strictly experimental, and originaed by the Dr, then his chancs of getting sued and losing are pretty strong. If you recall, the FDA has been trying to crack down on off label use, especially in the device industry. Many of the orthopaedic company's were using there Custom Implants Groups as a means to woo over Docs to there company's products by making a speciality designed implant for him. This practice is pretty much stopped with minimal use in real emerg. situations. Drugs have seen similar types of restricted activity, but the practice is so wide spread it is much more difficult to control. Especially with most of the Big Pharma's being at the forefront of expanded indications.
Expanding a label doesn't necessarily take years. Immunex expanded their label for Enbrel (Rheumatoid) to include Psoriatic Arthritis fairly quick and the trials are not even close to the orignal clinical trials in length. Definitely not years. I know ABT is already loooking to expanding D2E7 especially with the Immunex Enbrel shortage. Doc's are reluctant because insurance co's won't approve an expensive biologic that is not "labeled" for other similar conditions.