Bioelectronics Corp (BIEL)

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I'll try and answer your questions the best I can Super.

> (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?) Not sure what you mean by 'explain away', but every device must have a MOA. This is where the 'scientific evidence' comes into play. Whatever the MOA is, they need scientific evidence that is actually exists - this effectively removes any erroneous results from the 'placebo effect'. It's one of the criteria for clearance (As Andy clearly stated, but it is not the ONLY criteria)

> 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. Could be, I just couldn't follow the sentence. I don't know what data they have that heating pads are not the preferred mode of treatment. These are the open-ended statements that we have all grown to love from Andy

> 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? With a small company, this would need to come from outside consultants, both on the regulatory affairs side (these are the folks that deal directly with the FDA) and also clinical folks who would design the studies and manage the data.