Replies to post #79534 on Bioelectronics Corp (BIEL)

[DDGUY]

its like having to wait until everyone=dies-of-pain?

[Simpsonly]

Anything can be done in a week, if it is a matter of claiming victory, in order to follow a preferred protocol of clearance. . . . there is probably nothing the FDA doesn't already know . . . . .I sense de novo and 510(K) are 6 of one, half a dozen of the other . . . . .but to some, being right is more important than substance, thus the often expected conflict with simply gettin 'er done!!! No question, the >140Million Americans suffering every day with acute or chronic pain should be driving the 510(K) Clearance for OTC in the USA, one wonders if it is . . . . Someone, perhaps the good Dr. Califf, will find the courage to ask a quiet question, "would it be alright with you folks if you stopped piccing about and cleared this device, so we can do the job we're supposed to do and help our people?" When that happens, ActiPatch Tsunami