Hello all,I want to cast some hope about trials in the US.
In the mean time all of you keep on your doctors to apply to the FDA to get an IND# and then, with that in hand, to apply to get DCA for "compassionate" use. The person your doctor needs to contact at the FDA regarding compassionate use is Dotty Pease (she may also have helpers not sure) she's in the Oncology Investigational drug section. She can help your doc get you on your way to getting that all holy "FDA IND #" (Investigational Drug number" which you need to even apply for compassionate use for one person and which one also needs to have to optain DCA to do clinical trials with.
Since we first read the full text of the Michelakis paper, in Cancer Cell around 1/24/07...We have been working on/writing the protocol to submit to our local IRB and applying for the FDA IND # ...nite and day...Also trying to get it for compassionate use for one of our patients with Pancreatic Cancer (nite and day) This also necessitates getting an FDA IND # unfortunately before you can even order DCA from TCI america.
Very frustrating process but we are determined and tenacious. This will take several months - we will not be able to present our protocol to the IRB until April 1st. Then if approved by them... another month or 2 to get things up and running possibly. But a small but *driven* group of us are working as hard and as fast on this as we humanly can, without pay (for now)and without donations (for now) - but soon we will have a site up and be asking for donations to help with our trials (probably in the next 2-4wks). I will keep everyone posted.
For now....we are living on cold vegetarian pizza, strong coffee, 70% dark chocolate, hot ginger, and adrenalin. Lots and Lots of adrenalin...
Think of us; eat healthy; keep your fingers crossed; and say some sort of thanks to The Great Warburg (too bad he didn't live to see all this...but maybe he's watching).
It's 2:30am ET...
Sleepless in _ _ _ _ _ _ _ _ _ _ _,
"Z"
PS check out the kurosawa blog also (excellent resource and science based which i love): http://www.grouppekurosawa.com/blog/