Replies to post #60171 on Bioelectronics Corp (BIEL)

[JustGoDeep]

False, the company does not need the FDA to make it, FDA is the Icing on the cake!!

[DewmBoom]

There was no reclassification to Class II in 2011. FDA changed their mind based on evidence and reclassify the SWT to Class II very recently remember. Also, remember what Biel said about their filing:

“I am pleased with the strength of this filing and confident that it will satisfy the agency staff,” said Andrew J. Whelan, President and CEO. “We felt the overwhelming nature of our evidence, the solid legal and regulatory support from the law firm of Goodwin Proctor, and the American consumers’ dire need for safe pain relief warranted filing. Our request for over-the-counter market clearance is strengthened by three clinical trials on ActiPatch use in osteoarthritis knees, plantar fasciitis and post-operative pain, our explanation of the mechanism of action, the overwhelmingly positive results of the recently published United Kingdom and Ireland Registry assessment of 5,000+ users, our surveys of users published this week in Pain Management, and the sale of hundreds of thousands of devices.

DewmBoom Rating: Strong Buy

ActiPatch Exponential Growth Beyond Imagination