Bad news - FDA

Tom

There is no information on the FDA website on the Prodisc. The FDA does not list what is waiting for approval. My information that the Prodisc is (hopefully) to be approved in the 1st quarter of 2006 came from my Dr. and from info that I found on financial investment sites. What I was referring to on the FDA site was the proposed calander for the advisory panels. Hopefully approval will be made without going to the committee. If however it does go to the committee and the committee does meet in July, we will not even know if it is on the agenda until only several weeks before the meeting.

[Mariaa]

I think this is the 510k process I asked my OSS about last time I saw him re Prodisc approval, he said there weren't enough similar implants already approved by FDA. He said there needed to be 2 or 3 similar products already approved before Pro disc would be approved without going to the committee.
(I'm only repeating what he said, not believing it entirely as I do remain hopeful)...

I had asked the question in another post re how many like products must be FDA approved before another one would be approved thru 510k process. I saw no reference to # of similar products needing to be FDA approved before another one could be approved without going to committee.

Maybe those of us awaiting Prodisc approval in early '06 will get our wish, Feb's my Bday month so I'm really hoping so~

[letteski]

As a patent in the ProDisc study I must say that it is well monitored. I have to fill out loads of NCR forms as the study coordinator looks over my shoulder. If I miss anything or make a mistake she is there to sign her authority over it. While I meet with Dr D she sits in the room and takes notes. She doesn�t miss a thing and runs a tight ship. Hopefully this will all help with the approval in the end and the fact that Dr D has said that they will not need a meeting will come true and soon. I will see him again at the end of Jan for my 6-month appointment.

Hang in there those of you that are waiting it will be worth it.

[Harrison]

Just make sure you read the print...I fell off my chair laughing when I saw "death" as a possible complication...I had visions of Monty Python skits (I'm not dead yet!)

Alikin, what's your latest thinking on next steps?

Wellllllll, maybe I posted too soon. I just found another updated page on the FDA website that says that the committee has proposed meeting dates of Feb 2nd and 3rd. Fingers crossed!!!

(See here. Edited for formatting reasons.)

Mariaa, I hope the approval is in time to be a birthday gift for you. Since mine is in March it works for me too!

[Mariaa]

Alikin,
Thanks for this~ I'm really hopeful. Fingers and anything else that counts crossed!!!!!

Alikin:

Thanks.

Does anyone have any thoughts on a timeline for insurance companies post-FDA approval?

Or are you guys just trying to save the airfare to Europe? What am I missing here?

Tom

[Mariaa]

My OSS told me that even if Prodisc is FDA approved it would be at one level, then it would likely be another 3 years before it would be stated that it's approved for multiple levels, and then another 3 years for WC to approve it...

He also told me I wouldn't get SSD on first try and I did so while I have great respect for him, unless I see some factual evidence for what I was told, I take it with a grain of salt...

Mariaa:

Thanks. That agrees with my impression that insurance companies will take some time after FDA approval of the ProDisc.

However, Dr. Zigler told me that after FDA approval, he will be able to do multi-level disc replacements "off label." I think that's the term he used.

(I don't know what WD or SSD stand for.)

Tom

Wow, looks like we're all getting different information and why does that not surprise me! My doctor led me to believe that the Prodisc approval would be for two levels and he refuses to do off label procedures.