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Nancy L · 09-09-2012, 11:33 AM

Phil, I had radiation to reduce the pain caused by the tumor pressing on the bronchial plexus. They told me the radiation would not eliminate the tumor. The problem is the way they write the inclusion criteria. You must have regressed on your most recent protocol, which for me they say is radiation, not tykerb. The trial coordinator for Th3resa said the tumor would have to start growing again to qualify for expanded access. But my husband is going to call either Genentech or Stockton tomorrow morning and plead my case.

I am curious---if the FDA is going to fast track and approve this year, why would Genentech set up EAP for just a couple of months???? I could understand doing so if it was available at all trial sites. But having only three makes access very difficult for most women. I didn't realize how screwed up the FDA is untill I got involved trying to participate in a clinical trial.

09-09-2012, 11:33 AM	#26
Nancy L Senior Member Join Date: Apr 2009 Location: La Quinta, Ca Posts: 253	Re: TMD1 is coming! Phil, I had radiation to reduce the pain caused by the tumor pressing on the bronchial plexus. They told me the radiation would not eliminate the tumor. The problem is the way they write the inclusion criteria. You must have regressed on your most recent protocol, which for me they say is radiation, not tykerb. The trial coordinator for Th3resa said the tumor would have to start growing again to qualify for expanded access. But my husband is going to call either Genentech or Stockton tomorrow morning and plead my case. I am curious---if the FDA is going to fast track and approve this year, why would Genentech set up EAP for just a couple of months???? I could understand doing so if it was available at all trial sites. But having only three makes access very difficult for most women. I didn't realize how screwed up the FDA is untill I got involved trying to participate in a clinical trial.