Replies to post #110714 on Bioelectronics Corp (BIEL)

[JustGoDeep]

DING DING DING DING DING!! And We Have

a Winner of Biel Post of the Day!!

Hang on with BOTH fists!!

[Miamifl]

Well put post Jim!

[Duke2484]

"On the delay;

Only after FDA clearance was the company able to begin working with lawyers and FDA on new packaging and advertising langueage.

After that, they can design and order the packaging

Then they can ramp up production and fulfillment of the product."

Wrong. Packaging and any marketing advertisements are part of the 510(k) submission.

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134572.htm#link_3

"Even shipping and customs take some time from china to USA."

Now that I will agree with.

If my company had a 15 year head start we would have everything lined up in anticipation of 510k approval. BIEL and its management, not so much.