Since you ladies and gentlemen are the smartest, most well -informed group of people on the planet, I thought there might be some of you familiar with the FDA's process for obtaining access to investigational drugs outside of the clinical trial setting.
The background on this is that I have some progression of disease in my lungs now and I am not super excited about going on yet another chemo. I'd much rather try out a HER2+ targeted therapy such as Neratinib - made by Wyeth. As most of you know, it is in clinical trial phase right now and showing great promise. It also crosses the blood brain barrier which is huge news for me since I've had brain mets.
The problem is that the exclusion criteria for the clinical trials is too strict as it doesn't allow prior Tykerb/Xeloda usage.
So I am investigating the possibility of applying for emergency use via the FDA's new rule regarding such use. The new rule was just passed in August 2009 and take effect 60 days later - conveniently that is right now! Here is a link to some information on the rule if you are not familiar. It may come in handy for some of you down the road:
http://www.fda.gov/ForConsumers/Cons.../ucm176845.htm
My question is - has anyone here every applied to the FDA for such use? They call the form an IND for "Investigational New Drug". Any advice, insite, would be greatly appreciated.
Cheers!
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