Archives for category: LYME DISEASE AWARENESS

Not a great day. Weak sales translated into an opportunity for people to short the stock to the tune of a 25% drop.

Not pleasant, but wasn’t this whole run up fueled by a  short squeeze on traders who were caught by surprise when the NHS announced subsidized payments on the ActiPatch? These guys make the market.

The expression “keep your eye on the prize”. Where you want to be on the day the FDA announces General Clearance is  sitting on a couple million shares of BIEL. The first two FDA clearances were not long after a successful FDA meeting. This is where the new lawyers for BIEL explained to the FDA why the ActiPatch should be OTC.

As per Andrew Whelan, once BIEL gets that third clearance (Back) this will translate into a General Clearance. General Clearance is your money melon, and the main reason I am troubling myself to hold on to this stock.

Let’s see what BIEL has to say after the May 29th FDA meeting. 8 trading days left till it, then maybe 2 to develop a press release.

After this stock hits, the next stop is physical silver. I mean to stay poor, even after I get rich.  Poverty is your treasure, don’t lose it, as the Buddhist koan goes. Silver is a ticking time bomb.  The Implosion in 2008 was partially fueled by the wheels coming off the silver rig. Buying mining stocks is pointless. Just get physical.  Plus, BIEL has taught me something–I hate the stock market. I aim to get rid of that third party risk.

Since JP Morgan will be rigging silver for the foreseeable future, I can wait for BIEL to outwait the FDA, who must eventually run out of excuses. I think TENS has more at stake in stopping BIEL then the dreaded Opioid cartel at this point.

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Winding up May 15th, 2018.  Bioelectronics will most likely release a statement about the May 29th FDA meeting by June 1st, 2018.  While BIEL cannot comment on the General Clearance meeting which took place on May 9th (or so) while in process, it might well provide some hints included in the May 29th release on the separate FDA application for wound healing. This would be the tactful way.

Waiting for  the “ink to dry” on the Doctor Scholl’s agreement. I have a pen here at home I could have lent them, usually  dries completely in about thirty seconds. I admit it is not a very special pen, I think I lifted it from a bank, but I would have been happy to donate it, for future reference.

 

This is interesting

(Thanks to TAZZER from the IHUB board).

I interpret this to mean we are at Day 60, proceeding with the Interactive Review.

Hope this individual is correct.

 

Expedited Access Pathway Program

The FDA recently published draft guidance on the Breakthrough Devices program. You can submit your comments on the draft guidance, which describes the policies that the agency intends to use to implement the program, by December 26, 2017.

On December 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.

The Breakthrough Devices Program expands upon the Expedited Access Pathways (EAP) program by making future 510(k)s eligible as well as Premarket Approval applications (PMA) and De Novo device submissions. All participants previously granted EAP designation will have designation as Breakthrough Devices; no separate action is necessary.

For any questions about the Breakthrough Devices program or EAP, please contact CDRHExpeditedAccessPathway@fda.hhs.gov.

The Expedited Access Pathway (EAP) program is a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket notification (510[k]) or requests for De Novo designation. The program is detailed in the FDA’s guidance Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.

Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA’s PMA approval standard of reasonable assurance of safety and effectiveness, the standards for granting De Novo requests, or any other standards of valid scientific evidence.

Components of the program include priority review, more interactive review, senior management involvement, and assignment of a case manager. The extent to which the FDA provides these features depends on the availability of resources.

Participation in the EAP program is only at the request of the sponsor and with the FDA’s agreement. If the FDA determines that a device may be eligible for this program and the sponsor has not yet submitted a Pre-Submission (Pre-Sub) requesting EAP Designation, the FDA intends to inform the sponsor of the program. For details on how to request feedback from the FDA, see FDA’s Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff.

Devices eligible for EAP Designation

Devices subject to premarket approval applications (PMAs), premarket notification (510[k]) or requests for De Novo designation are eligible for EAP designation if the following criteria are met:

  1. Provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.

AND

  1. The device meets at least one of the following criteria:
    1. Represent breakthrough technologies;
    2. No approved or cleared alternatives exist;
    3. Offer clinically meaningful advantages over existing approved or cleared alternatives including the potential, when compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or
    4. The availability of which is in the best interest of patients.

When to Request EAP Designation

The FDA strongly recommends sponsors interested in participating in this voluntary program contact the FDA early in the development of their device. In most cases, a sponsor should request EAP designation prior to beginning an IDE pivotal study so the FDA and the sponsor can make sure the data being collected in the pivotal study are appropriate to include in the device’s marketing submission.

Sponsors who are developing a device that may qualify for EAP designation and would like to be considered for the program should submit a Pre-Sub following the procedures described below and explained in detail in the EAP guidance.  The FDA encourages sponsors to contact the appropriate division/branch to alert them of their plan to submit a request for EAP Designation prior to submitting it or at the time of submission.

Submitting a request for EAP designation

The request for EAP designation should be a standalone submission (i.e., no other requests are included with the request for EAP designation) and submitted as a Pre-Sub to the appropriate Center’s Document Control Center. The current mailing address for CDRH’s DCC and a link to CBER’s DCC’s mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

Pre-Subs are not subject to a user-fee. However, you must submit an eCopy (per section 745(A)(b) of the FD&C Act).  For information about how to comply with the eCopy program, please see the FDA’s guidance document eCopy Program for Medical Device Submissions.

Submissions should be written in the English language. Any material in a foreign language should be accompanied by an accurate and complete English translation.

Content of a submission requesting EAP designation

A Pre-Sub requesting EAP designation should include the following information:

  • Cover Letter clearly noting the purpose of the Pre-Sub stated as: “Request for Inclusion in the Expedited Access Pathway Program, as described in the Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions Guidance, issued on April 13, 2015″ and a statement of whether you believe you are eligible as a PMA or de novo candidate.
  • Table of Contents
  • Device Description
  • Proposed Intended Use/Indications for Use
  • A discussion of how your device meets the EAP eligibility criteria
    • Include a discussion of why the device meets the EAP criteria described in section III.C of the EAP guidance, including any relevant supporting documentation
  • A draft Data Development Plan (Optional)
    • A description and summary of the data collection plan, including study synopses and study design.
      • Outline of nonclinical & clinical testing, planned or already completed
      • Proposed Labeling
      • Summary of Nonclinical Studies, including study design & protocol, as available
      • Summary of Clinical Studies, proposed or completed
    • Explanation and justification for the proposed balance of premarket and postmarket data collection, if applicable.
    • A timeline for the development and marketing of the device, and for the postmarket data collection, if applicable.

The Agency developed two Data Development Plan examples, Example 1 and Example 2 to offer a format for the organization of the information in a draft Data Development Plan.

These examples are equivalent and differ only in formatting. The information provided in these examples does not create new requirements or expectations for affected parties, nor are they intended to convey FDA’s recommended approaches or guidance. Rather, these are examples of how the Data Development Plan information recommended in the EAP guidance could be organized.

FDA Response to requests for EAP designation

  • The FDA intends to notify the sponsor of its determination in writing within 30 days of receipt of a request for EAP designation.
  • If there is insufficient information for the FDA to make a decision about EAP designation, the FDA may request the sponsor submit additional information.
  • In response to such request, any additional information provided by the sponsor should be submitted as a supplement to the Pre-Sub.
    • If the FDA requests additional information from the sponsor, the FDA will notify the sponsor in writing whether or not EAP designation is granted within 30 days of the date of the request for additional information.
    • If the FDA has not received enough information in time to make a decision by 30 days after a request for additional information is sent, the FDA intends to deny the EAP designation.

Benefit-Risk considerations

The FDA’s Benefit-Risk Guidance explains the principal factors that the FDA considers when making benefit-risk determinations in the premarket review of certain medical devices, including devices subject to PMAs. Two of the factors that the FDA may consider as part of making benefit-risk determinations are postmarket data collection and uncertainty.

The FDA may accept a greater degree of uncertainty of the benefit-risk profile for these devices if the uncertainty is sufficiently balanced by other factors, including the probable benefits for patients to have earlier access to EAP Devices (e.g., devices that treat a life-threatening disease when no alternative treatments are available), and adequate postmarket controls to support premarket approval.

As part of the FDA’s benefit-risk determination, the FDA intends to weigh the device’s impact on patient health, including the probable benefit of earlier access to the device, against the probable risk of harm to patients from the device should subsequent data collection demonstrate that the device is ineffective or unsafe.

Role of Postmarket Data for EAP Devices Subject to PMA

As part of the EAP program, the FDA intends to work interactively with the sponsor within the benefit-risk framework discussed in the FDA’s Benefit-Risk Guidance and in accordance with statutory and regulatory requirements, to determine whether certain data may be collected postmarket rather than premarket.

Getting the right balance between premarket and postmarket data collection – specifically, where appropriate, a greater reliance on postmarket collection – can reduce the extent of premarket data submission and directly impact when patients will have access to high-quality, safe and effective medical devices.

Section 513(a)(3)(C) of the FD&C Act requires the FDA to consider the use of postmarket controls in lieu of collecting and reviewing all effectiveness data prior to PMA approval.  In addition, section 513(a)(3)(D)(ii) of the FD&C Act (the “least burdensome provision”) specifically provides:

Any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary that such data are necessary to establish device effectiveness.  The Secretary shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval.

The consideration of postmarket information as part of premarket review is discussed in the FDA’s Benefit-Risk Guidance as one of the principal factors that the FDA considers when making benefit-risk determinations during the premarket review for devices subject to PMA, and is consistent with the FDA’s guidance The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles (“Least Burdensome Guidance”), issued October 4, 2002.

Postmarket requirements as conditions of approval for PMAs under the EAP program

The FDA intends to impose postmarket requirements, including requiring post-approval studies, as a condition of approval for devices subject to a PMA when applicable.

EAP designation denials

Even if your device does not qualify for EAP designation, you can utilize the pre-submission process to request feedback from the FDA. Please see FDA’s Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff for details on how to request feedback from the FDA.

EAP designation revocation

An EAP designation will not be revoked solely because a similar product is approved or a de novo request granted. The FDA may revoke an EAP Designation at any time prior to approval upon written notice to the sponsor if the FDA determines that:

  • Based on information available, the device is no longer eligible for an EAP Designation according to the EAP criteria outlined in Section III.A of the guidance; or
  • The information submitted in support of a request for EAP Designation, including, without limitation, the Pre-Sub package, or any related premarket submission contained an untrue statement of material fact or omitted material information, including false statements relating to data collection.

As a general matter, the FDA does not intend to revoke EAP Designation for other reasons.

A fairly ideal outcome for this press release-These applications are very template driven, the hard part was the creative effort to invent this and get through all the other hurdles.

IHUB is going to get ugly near term until the recent spate of orchestrated stock shorters throw in the towel. Last FDA approvals, it took several days for the stock to really spike. I think this news needs to sink in, be understood and digested by the investing world.

No new testing required and the previous 510K submission can be used. Approval for the back means full OTC General Clearance. Migraine, Menstrual, Carpal Tunnel, everything can go easier, not to mention post surgery coming up on May 29th.

 

BioElectronics Receives FDA Pre-Submission Approval for its Relief of Musculoskeletal Pain Market Clearance Application

GlobeNewswire

FREDERICK, MD , May 11, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to report on the outcome of its Pre-Submission meeting on May 9th, 2018 with the US Food and Drug Administration (US FDA). The FDA’s Pre-Submission Program is designed to organize and give guidance and feedback on clinical data and what regulatory pathway should be followed to get market clearance. The focus of the May 9 pre-submission meeting was in discussing the FDA’s feedback on the clinical outcomes and statistical techniques used in reporting the back-pain study.  

Upon reviewing pre-submission information on the ActiPatch® back-pain study (https://clinicaltrials.gov/ct2/show/NCT03240146), the FDA provided positive feedback on the clinical results, and guidance on a 510(k) submission to obtain expanded market clearance for over-the-counter (OTC) treatment of musculoskeletal pain. This would make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans (one in two adults) who are suffering with some form of musculoskeletal pain. While ActiPatch is already FDA cleared for treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (1 million annually), expanded market clearance would allow additional products for the back (42 million), neck (19 million), hip (9 million), shoulder (11 million), carpal tunnel (12 million) and many other musculoskeletal complaints.

The company was represented by their clinical R&D team comprising: Sree Koneru, Ph.D., VP Product Development, Ian Rawe, Director Clinical Research of BioElectronics, Kenneth McLeod, Ph.D. Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D. Professor Duke University. Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.

An additional pre-submission meeting is scheduled with the FDA on May 29th, 2018 to seek expanded indications in a separate application for OTC treatment of pain and edema following surgical procedures for its RecoveryRx® medical device.

About BioElectronics Corporation

May 9th has a few saints of special interest I found, as I was perusing Butler’s LIVES OF THE SAINTS this morning.

Saint Pachomius, one of the founders of monastic life in Christianity,  was plagiarized by Karl Marx and never given attribution. Saint Pachomius’s version was based on communal living through the teachings of Christ. Supposedly, he had these teachings from an angel, who gave him a brass tablet with instructions on it.  Shades of Mormonism there. Some say Saint Pachomius, who died in A.D. 348, spent some time in pagan temple before his conversion and got some organizational ideas from that. He had 24 character types using the 24 letters, and assigned a type to each individual monk.

Marx ripped the guts out of Saint Pachomius’s teachings, and replaced Jesus with a kinder, gentler, machine gun hand (thanks Neil Young!).

Saint Gregory Nazianzen, the reluctant bishop of Constantinople, has a message for this day, I think. Quote:

“He (God) gives with greater joy than the joy with which we receive. Only let us not be too apathetic in our petitions, or set too narrow bounds to our requests.: nor let us ask for frivolous things, which it would be unworthy of God’s greatness to propose that He should grant us.”

When persecuted by the Arian Heretics and Apollinarists , Saint Gregory reflected that although his adversaries were the stronger party, he had the better cause.; though they  had the churches, God was with him; if they had the populace on their side, the angels were on his.

Great old used books are haunted creatures. One opens up a page at seeming random and discovers an insight, but it makes sense the book opens to a natural bookmark created by someone else who read the same passage frequently.

Today is an historic occasion, not frivolous at all. Bioelectronics Corporation is meeting with the FDA to try to get full clearance for the world’s first electroceutical aspirin, an approval long denied by the bundlers for Hillary Clinton installed as the heads of the FDA by the previous administration. Margaret Hamburg, who has been dealt with in this blog before, pushed the opioid agenda so she and her hedge fund owner husband could rake in hundreds of millions of dollars. Hillary was bribed, and pain sufferers died.

All supporters of Bioelectronics are asking for is fair play so a safe, effective device can be legally marketed in the USA, as it can be in most of the civilized world. This company and this technology are on the side of the angels. What side is the FDA on? I guess we will find out this month. History comes in waves, and if I was the FDA I would remember ultimately their best job security is to do their jobs, not the job of the opioid cartel.

Greetings Friends,

What do Dr. Oz, Lou Ferrigno, and Bill Belichik all have in common?

President Trump appointed them to his council on sport, fitness and nutrition.

What else do they have in common?

I have mad respect for each of them, for different reasons.

Lou Ferrigno is a partially deaf person who famously prompted Arnold to move on from bodybuilding because he knew his days were numbered as a champion when he saw Lou. This is documented in the classic film Pumping Iron, which was one of Arnold’s first forays into film. Arnold psyched out Lou’s father, who then psyched out Lou to pull out the win. This movie was deep, and well worth watching. Ferrigno was also known as being a non-steroid user.

Bill Belichik–love him or hate him, he usually beats the point spread.

Dr. Oz–I like this guy. I think he is actually a fairly sincere humanitarian with an unusually open mind. His detractors view this as a liability. Dr. Oz is an early advocate for Bioelectronics and SWT therapy.  He plugged the ActiPatch on his show once, and I think they sold about a hundred thousand of them in a day.

Posted below is a great summation of May for Bioelectronics. Trying to amplify the reasonable posts a bit. I added some underlines, boldfaces, and italics.

One thing I learned, which I want to verify, is that BRAUN is a private company (?)!! I have never actually tried to buy BRAUN stock, so all I know is bottom line stuff like they are a big German outfit that does some crazy number for gross each year. It explains a lot about how they operate. They play it pretty close to the vest.

*Note, when SRINSOCAL talks about a huge trading day with major upward pressure, bear in mind the incredible short position there is on BIEL stock., and also that the stock price, though strong, has not yet corrected to a sensible level. We should be at 3 cents a share, easily.

BIEL Triggers

by srinsocal

BIEL Triggers…

May 15th Q1 Financial Report – If BIEL can show a significant increase in sales, most likely caused by the NHS ramp up, this will support the company statements that “the NHS win is transformational for the company”.
Other revenues from Licensing/Co-branding have been said to possibly show up as early as Q1.

May 9th FDA Back Pain Meeting – BIEL should provide a statement shortly after this meeting. The FDA wanted a Clinical Trial on a third body area to consider a “Full Body Clearance”. BIEL has provided a 100 patient Back Pain Trial to support the addition of the Back as an indication for ActiPatch and Full Body Clearance. Those with knowledge of the process have indicated that a new 510k will not be needed but rather that the Back will be treated as an addition to the successful 2/3/2017 Clearance for Foot and Knee. 

May 29th FDA Post Operative Pain Meeting – Data was sent to FDA, BIEL received a quick response for the 5/29 meeting. IMO this should be a Slam Dunk with the B.Braun surgical use in the UK and now with the new NHS/B.Braun “Total Pathways Program” rolling out. 

Time frame, Any Day Now, Bayer/Dr. Scholl’s Partnership – On 4/26 BIEL’s VP of Sales stated that BIEL was “close to finalizing a deal to partner on a product with Dr. Scholl’s”. Dr. Scholl’s is owned by Big Pharma Giant Bayer. When this gets a PR we will see a billion share trading day with Extreme Upward Pressure. 

* Time frame, Any Day Now, MundiPharma Distribution– “Australia and 8 other countries” KN. Mundi is a global billion dollar company. This deal has not yet received an official BIEL PR, when it does it is another big catalyst for the BIEL SP.
Time frame, Any Day Now, Performance Health (formerly Patterson Medical) – Another billion dollar global company wanting to do distribution business with BIEL. As with Mundi waiting on an official PR stating Performance is a distributor which gives BIEL instant medical community credibility. 

Time frame, Any Day Now, B.Braun/NHS Total Pathways Program – This was the Big Surprise from the latest KN interview. There was speculation re the Dr. Scholl’s Deal for months so the 4/26 confirmation was fantastic but it was a possibility. The B.Braun Total Pathways was a complete surprise. Those darn privately held companies can sure keep their secrets. Major Plus, placing joint surgery patients on ActiPatch while they wait for surgery as this wait can last a year. Once again when this gets a BIEL PR major boost for the company. 

This is only a partial list of events that will impact the BIEL SP. We did not even touch on the prospects for the Migraine Clinical trial, the Menstrual Pain Clinical Trial, or the Total Knee Replacement Trial. I am sure there are several other events that are on the horizon that I am missing.

BIEL has a stock pile of fuel and will keep things exciting throughout 2018!

 

Keith Nalepka updates:

The VP at BIEL updates–FDA meeting on May 5 and May 29th.

He name drops Dr. Scholl’s (owned by Bayer), and says a lot is happening with partnerships. He would not mention Dr. Scholl’s unless it was basically a done deal

This stock is valued at about 40 million.

This guy is who you want on the radio.

My analysis? Doesn’t matter much. Events are unfolding beyond the scope of even the Zombie World Order blog, which gives some indication of the magnitude. Listen to the interview, linked above.

I’m just going to try to hang tough, and focus on living correctly.  What matters is we maintain the courage of our convictions in all things.