Replies to post #135642 on Bioelectronics Corp (BIEL)

[Rheeper]

this is helpful. Did you speak with Andy?

[PashkaVl]

Thinking BIEL is waiting until full body clearance before completing the Dr Scholls deal.

If they're able to market that it will help treat all Musculoskeletal Pain in the foot rather than just Plantar fasciitis, Andy and Co can demand multiples more in value from the licensing deal... think about it.

As for me, 9 years later, what's another 4 months to wait for the real fireworks to start?!?

And up or down always remember, we're the good guys fighting the good fight here... This technology and company reduces pain and suffering and if successful, in the long run, will save the global healthcare system 100s of billions of dollars and countless lives from reducing the reliance on narcotics.

Be proud of this investment and good luck to everyone!

[TruthBeSaid]

New indication vs new intended use

The FDA makes a somewhat subtle distinction between these two, the second requiring a new 510(k). Even in the first case a special 510(k) or an abbreviated 510(k) is required. You cannot have a pre-sub meeting and be cleared. The pre-sub is a specific process at the FDA (a pre-submission meeting, which means to discuss an upcoming submission). The clearance happens after the submission and evaluation which follow any pre-submission.

Look at these documents:

pre-submissions:

https://www.fda.gov/downloads/medicaldevices/.../ucm311176.pdf

New 510(k), when?

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134575.htm

The bullet items and the last paragraph answer the questions here.
I saw someone posting about a supplement or amendment and be done - there are no such things for a 510(k).

A back clearance involves a new patient population - the ones with osteoarthritis or plantar fasciitis are not the same as the ones with back pain and in our case with broader musculo-skeletal pain clearance this is definitely a new and much expanded patient population.

Having said all this, it is still the case that we have very good clinical data for back - the p-value is 0.001 (Sree Koneru presentation; for composite outcome index - will translate ~ 0.006 for individual efficacy end points). The FDA and the community generally consider < 0.05 as the cut-off for proving efficacy. The plantar fasciitis study had < 0.03, the osteoarthritis had similar to the back, both about 10-20 times better than the FDA unwritten cut-off of ~ 0.05 for statistical significance. Considering also the FDA's new familiarity with the technology and recent acceptance - it is all fresh, the iron is still hot - I do expect the process to be an easy and quick one. But not as quick as clearance at the pre-sub meeting today. You have to be realistic.

I suggest that the board drop the expectation of clearance today - wrong expectation is sure recipe for unhappy outcome. Some positive news from the meeting is all that I expect. Don't be disappointed and sell if a clearance doesn't happen today - probably that is going to happen => a buying opportunity. One can expect clearance relatively quickly after that, after 510(k) submission. Also, I fully expect the FDA to do a press release or some such tom-tom after the full musculo-skeletal pain clearance as that is a big step in the context of the current opioid situation. The FDA needs to tout their successes in efforts to counter the opioid crisis. For once, BIEL is at the right time at the right place. Doesn't happen often.

Finally, uksausage: during your upcoming UK visit, please do chat up the floor persons or the checkout clerk to collect as much intelligence as you can. How well is it selling, has there been a fillip since Apr 1 prescription coverage, do people come in knowing about it, why is it not available on-line etc. Thanks for your efforts.

[art2426]

>>>According to Keith, BioElectronics is not just trying establishing a brand, but "to establish the process to a standardize care for pre and post-operative pain."<<<


HOW BIG is THAT!!!

Standardize care"!! Wouldn't that be something if we are talking about a routine for most every surgery in every hospital throughout the world!!

Recovery RX was an afterthought to me, as Actipatch and Allay I felt were what was going to be the big sellers. And they probably still will be. But IF Recovery RX can ever really get to be the 'standard of care' in surgery, that would be HUGE!! I mean HUGE! If this ever occurs, that would get the attention of all MD's (not just surgeons) and they would be prescribing all these products to all their needy patients.

I cannot wait to hear my wife (surgical nurse) come home one day and tell me' "Guess what we used today for our pre and post op patients?"

This is getting interesting!
This is getting fun!
This is getting serious!