Wednesday, February 26, 2014 9:13:42 PM
> (You may have explained this before), but how far does BIEL have to explain away the mechanism of action before they (FDA) gives their approval (on just that part?)
> Also, that BIEL statement with your follow up: "It is not the FDA that could not explain it, it was BIEL. The burden is on the firm, not FDA Over the years, pulsed versus continuous therapy has become the preferred mode of treatment.Compared to...what?" ....I understand that the burden is on the firm - great point. I just thought that the continuos therapy they are referring to is the heating pads that can cause burns because they do not pulse.
> Who can help BIEL make sure their applications are spot on this time? Who can help or how do these other companies (assuming the product efficacy and safety are already there - just need to be proven by the company) actually prove their products worthy so the FDA clears them?
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