Bioelectronics Corp (BIEL)

[Simpsonly]

Sort of interesting waiting for a flight and thinking of next steps for BIEL. Went to FDA site, 2014 device approval page - link below.

Looked at 8 device approvals to date 2014, none in SWT category.

Shortest elapsed time application to approval 6 months with 3 amendments, longest time 50 months with 18 amendments. In the case of the longest elapsed time application-to-approval, there were 7 separate amendments in just the first 105 days following the original application and 18 amendments total in the 50 months elapsed time before approval. I checked the number of amendments to each device application and inserted those numbers below after the duration number.

Seems to me that the FDA worked with every applicant and the amendments kept rolling in until the FDA and the applicant were both satisfied, the FDA then took time to do its final assessment, review it, write an approval letter and issue it.

May one assume that in the classification space of devices that the FDA is proposing it create, and which if created BIEL will position itself, that there will be certain defined specification parameters of acceptability for the SWT devices that the FDA will instantly recognize as safe and efficacious? Like, frequency, current, pulses/whatever? I think, yes.

And, can one safely assume that there is a fresh genre in the FDA that devices are being viewed differently today than 5 years ago when BIEL was going through its application phase? I think, yes.

My overwhelming conclusions, based on what I see in the devices approved data for 2014 and from my personal experience with the FDA on an oncology drug, is consistent; that they do indeed work with applicants to move forward, not backward, and that if respect and diplomacy are used at every step of the way, then good things happen. In other words, be thorough in the application, make sure the science and back-up are credible, never wing it, say you don't know if you don't know, never BS them because they know what they're doing and never, ever picc them off! Seems like a plan. I also think the shorter approval time the FDA suggested for complete and thorough applications with no amendments is because they know what they're doing.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm381097.htm

DEVICE
Supera Peripheral Stent System <17 months 7
Nucleus® Hybrid™ L24 Cochlear Implant Sys <11 months 5
Elecsys® HBeAg Immunoassay etc. <10 months 3
MONOVISC™ injectable Intra-articular Device 50 months 18
Dexcom G4 PLAT Cont Gluc Mon Sys <12 months 2
Medtronic Valiant Thoracic Stent Graft < 6 months 3
Medtronic CoreValve System <7 months 2
ReSure® Sealant <11 months 5