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-   -   prodisc fda approval (https://www.adrsupport.org/forums/showthread.php?t=4676)

12-09-2005 01:23 PM

so, back last fall (summer??) the approval for prodisc didn't happen, and for some reason i thought that the fda was going to meet in october? maybe that didn't happen. has the meeting/approval be pushed off till 2006?

doug

letteski 12-09-2005 05:41 PM

Doug,

I think so, when I saw Dr Delamarter on Nov 16, I asked about the FDA approval. He said that because of the class action law suite against J & J and the Charite, the FDA is taking a good look at the FDA trials to make sure everything is OK. He hoped things would happen in Jan. But don't hold me to his speculation.

Once again Lawyers getting in the way, as we all can see from the Adds it is big business.

You can check the FDA meetings here.

Mariaa 12-09-2005 07:23 PM

My OSS said the same thing yesterday when I brought up Prodisc~ tho more like ?? as to the when it would be FDA approved..

12-09-2005 09:48 PM

there is a class action law suit? is there really a class action suit against j&j and the charite?

why am i surprised. as i write this, at the bottom of the page is an add for the artificial disc lawyer.


doug

Ann F 12-09-2005 10:12 PM

Folks, just got word yesterday from Dr Yue that he thought the pro-disk would be approved Feb 2006, then Activ-L trials would begin 90 days after, and it would be to compare pro disk to active-L.
Ann F

ans 12-10-2005 12:26 AM

The burden of proof is on the attorneys in these class-action lawsuits, and they're getting hard to win. It gets interesting with docs and biostatisticians from both sides battle it out imo. I wonder if the attorney's are taking claims on contingency which I suspect.


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