Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Reverse split coming. Buyer beware
INVESTORS UPDATE TOMORROW.
BIEL -----> Look at chart. About to break out. FDA APPROVAL COMING.
BIEL -----> Look at chart. About to break out. FDA APPROVAL COMING.
BIEL -----> Look at chart. About to break out. FDA APPROVAL COMING.
BIEL -----> Look at chart. About to break out. FDA APPROVAL COMING.
PLEASE SHARE YOUR DISPLEASURES ON HENNING MORALES FACEBOOK PAGE. HE WOULD LOVE TO HEAR HOW HE F**KED EVERYONE.
LOOK AT BIEL CHART. FDA APPROVAL COMING. CHEAP SHARES. LOOK AT UPTREND.
BIEL ----LOOK AT CHART. FDA APPROVAL COMING.
We will find out more next Thursday in the Investors Update.
Announcement of 510k submittal expected to be made before end of month.
INVESTORS UPDATE NEXT THURSDAY. LESS THAN A MONTH BEFORE RECLASSIFICATION. IT'S THE CALM BEFORE THE STORM.
FDA proposes new expedited access program for medical devices that address unmet medical needs
Agency also clarifies policy on when manufacturers can collect data after approval
Today, the U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.
The proposed Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (“Expedited Access PMA” or “EAP”) program features earlier and more interactive engagement with FDA staff—including the involvement of senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval—features that, taken together, should provide these patients with earlier access to safe and effective medical devices.
EAP is not a new pathway to market, but rather a collaborative approach to facilitate product development under the agency’s existing regulatory authorities. While other existing device programs have focused on reducing the time for the premarket review, EAP also seeks to reduce the time associated with product development.
“We are excited to offer a proposed program for expedited access for certain high-risk medical devices,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The program allows manufacturers to engage early and often with the agency. We expect most devices that enter this program will be in the pre-clinical trial phase.”
To be eligible for participation in the program, the medical device must:
• Be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition
• Represent one of the following:
1. no approved alternative treatment/diagnostic exists, or
2. a breakthrough technology that provides a clinically meaningful advantage over existing technology, or
3. offers a significant, clinically meaningful advantage over existing approved alternatives, or
4. availability is in the patient’s best interest
• Have an acceptable data development plan that has been approved by the FDA
The EAP builds on the Innovation Pathway pilot, which the FDA launched in 2011, and the FDA’s experience with expedited review programs for pharmaceuticals, including Accelerated Approval and Breakthrough Therapies. When utilizing the EAP program, the FDA will continue to apply the current approval standard of demonstrating a reasonable assurance of safety and efficacy.
In addition to the Expedited Access Program, the FDA published a separate draft guidance that outlines the agency’s current policy on when data can be collected after product approval and what actions are available to the FDA if approval conditions, such as postmarket data collection, are not met. Included in the guidance is advice on the use of surrogate or independent markers to support approval, similar to the data points used for accelerated approval of prescription drugs.
“To assure that a device is safe and effective and provide timely patient access to breakthrough devices, it’s critical to get the right balance between pre-market data collection and post-market data collection,” said Dr. Shuren.
The FDA seeks public comment on both documents.
• Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Draft Guidance for Industry and FDA Staff
• Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Draft Guidance for Industry and FDA Staff
For more information:
FDA: Medical Devices
BIEL -----GOLDEN CROSS ALERT-----
Going to be much higher than these levels soon.
$$BIEL$$ GOLDEN CROSS
BIEL ----Look at chart. FDA APPROVAL COMING soon
People gotta get these 26's no one wants to sell because we know where this is going.
Look at BIEL CHART. About to BREAK OUT and FDA APPROVAL on the way.
BIEL-----> Check out the chart. FDA APPROVAL ON the way. Start Loading.
$$BIEL$$ (?_?) LOOK AT THE CHART. FDA APPROVAL ON THE WAY.
Real thin after 26. Would be nice to close around 28
BIEL---- FDA APPROVAL COMING$$$$$
BIEL---- FDA APPROVAL COMING$$$$$
BIEL---- FDA APPROVAL COMING$$$$$
$$BIEL$$ LOOK AT ONE-MONTH CHART. BREAK OUT COMING.
$$BIEL$$ LOOK AT ONE-MONTH CHART. BREAK OUT COMING.
$$BIEL$$ LOOK AT ONE-MONTH CHART. BREAK OUT COMING.
ACTIPATCH. ALMOST 4,000 LIKES ON FACEBOOK. UP 1500 IN A MONTH
BIEL HEADING NORTH. BUY THE DIPS. LOOK AT THE CHART. ---FDA APPROVAL COMING---
BIEL buy the dips. Look at the chart. FDA NEWS ON HORIZON.
INVESTORS UPDATE NEXT THURSDAY
$$BIEL$$ CHART looks PRIMED for another run. FDA APPROVAL ON THE HORIZON.
BIEL CHART LOOKS SWEET. FDA APPROVAL ON THE HORIZON.
WTF, Bioelectronics Facebook page went from 700 likes to almost 14,000 anybody else see this. Hold on to your shares
Good call. Maybe by eow
May 21 a month away. Uptrend starting. About to be fun.
Might hit a penny today
BIEL CHARTING LOOKING GOOD. FDA NEWS UPCOMING.
$$BIEL$$ RUN STARTING. FDA NEWS COMING