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Letter from the FDA

Posted by Scott R on 12/07/01 at 11:50 (066432)

I got a letter from the FDA today. I'll scan it in when I have time. They say my statement 'According to the FDA the Orbasone can only be marketed for general pain relief without reference to specific sites on the body' is false and misleading. There are 2 problems with this. The first is that the statement hasn't been on the website for sometime (the last modification of the eswt page was a month ago as can be seen by anybody on the internet by the date on the file). The second problem is that it's a direct quote from an FDA letter. Signed by the same person who signed my letter. Sent to me by HealthTronics.

Re: Letter from the FDA

Scott R on 12/07/01 at 12:45 (066447)

An interesting aspect of their letter is that they modified my quote by taking out the quotes and leaving off my link to their document which obscured the fact that I was quoting them. I wonder if they were relying on information from a 3rd party who modified the quote.

Re: Letter from the FDA

BarbaraTX on 12/07/01 at 23:55 (066497)

So how much do you think that Healthtronics is paying some patsy at the FDA to sink the Orbasone? It is about the only machine in the US that is in-office, portable, cheap(er), and flexible, so you don't have to be put under to the tune of thousands of bucks. This totally, totally stinks. It is late, I am chilling with a Miller Light, and I feel like tellin' it like it is. B.

Re: Letter from the FDA

Scott R on 12/07/01 at 12:45 (066447)

An interesting aspect of their letter is that they modified my quote by taking out the quotes and leaving off my link to their document which obscured the fact that I was quoting them. I wonder if they were relying on information from a 3rd party who modified the quote.

Re: Letter from the FDA

BarbaraTX on 12/07/01 at 23:55 (066497)

So how much do you think that Healthtronics is paying some patsy at the FDA to sink the Orbasone? It is about the only machine in the US that is in-office, portable, cheap(er), and flexible, so you don't have to be put under to the tune of thousands of bucks. This totally, totally stinks. It is late, I am chilling with a Miller Light, and I feel like tellin' it like it is. B.