Cladrabine (oral pill) delayed - delay not quantified
 

http://www.bloomberg.com/apps/news?p...d=aiWakRM_EOoA

“Our next step is to request a meeting with the FDA,” said Schrimpf in a telephone interview. “We’re not in a position to discuss the details of the FDA letter.”

Thanks for the link...the types of cancer that were found in patients in the trial are kind of scary, IMHO...

This is the one my neuro spoke about as a possibility for me. He said that the people who got cancer had already had cancer before so he said it couldn't absolutely be attributed to the Cladribine.

I wonder how many patients were in the trial, including those on placebo? And were any of the placebo patients cancer survivors? I'd like to get all the details about this. :confused:

Wow, that's a serious disappointment for those people whose options are slim and were really looking forward to pills. Cancer of the placenta sounds quite bizarre--surely something that odd (rare?) is a drug side effect?

Cladribine never appealed to me because of the cancer stuff--I do find that scary. But I guess Fingolimod, the other potential oral MS drug, also has some skin cancer risks (melanoma).

Tysabri has also been linked to Melanoma. :(

I am simply not interested in anything, including Meds, that suppresses my Immune System. I realize that in the short term, they may help to slow MS, but, at what cost. How can suppressing the immune system,long term, ever be a good thing?

Hi Wiz, yes I know that Tysabri has been linked to melanoma but only 2 cases, right? And these were post-marketing? I think fingolimod has been linked to 6-7 cases of skin cancer in the clinical trials. Regardless, Sally is right on the money when she points to the dangers of suppressing the immune system.

I'm with these days Sally. Just the short time I was on them are having an affect on immune system (as they were supposed to). Sick all the damn time. I'm rooting for the blood flow problem and an easy surgery. ......Please? :D

I just put a call in to my neuro. I want to ask if I should go back to Tysabri or start Copaxone again. It's been two months now and I still feel good like I haven't even stopped Tysabri (as good as one can feel with MS fatigue.)

I mention this because I was assuming I could go on Cladribine in the spring but who knows how long it will take to be released now, if ever? :confused:

Probably a good idea as not mentioning why the FDA refused to file the application suggests it may be much more than an easy, quick administyrative fix.