One doesn't often get this Crystal Clear of a Heads Up in the Market
Recent BIEL Investor Updates relating to FDA:
1/20/2020 - FDA On-site Quality Audit
On Tuesday, January 14 the U.S. FDA conducted a quality systems audit at the Company’s manufacturing site in Frederick, Maryland. The two-day audit went smoothly, and no deviations/observations were identified in the Company’s quality management system. Additionally, the FDA provided several recommendations on how to continuously improve quality management and ensure global compliance, given that the Company’s products are exported to distributors in several continents such as MundiPharma SEA, and other potential distributors in Russia, South Africa and Ukraine with whom discussions are ongoing. Note that while the Company uses the distributor model internationally, an OEM-channel partner approach is being utilized within the United States.
The FDA periodically conducts on-site audits for registered medical device manufacturers to ensure that the manufacturing and distribution processes are compliant with federal regulations. The last FDA on-site audit for the Company took place in 2015.
<<< This Audit could have coincidentally occurred at the same time the 510k was close to Approval but odds are they are related>>>
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1/6/2020 - FDA Musculoskeletal Pain 510(k) Status Update
On January 3, 2020 the FDA requested a clarification of language on the labeling for our proposed indication for use (adjunctive treatment of musculoskeletal pain). We provided the FDA with this information on the same day. Additionally, we were notified that the FDA review team was evaluating the reports of our Electrical/Electromagnetic standards testing, and that they did not foresee any other concerns with the other portions of the submission that were not already interactively discussed. A final decision on our application is expected to be made prior to February 2, 2020 (90-day review mark).
<<<When the FDA starts asking questions about Labeling regarding a 510k it is time to Chill the Champagne as Labeling is irrelevant if the application is going to be denied. The FDA has taken a lot of Heat from Congress for delays in approving new medical technology. They take their 90 Day 510k Decision Goal very seriously>>>
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12/16/2019 - FDA Musculoskeletal Pain 510(k) Status
On December 11, 2019 the lead FDA reviewer of our 510(k) application contacted us via e-mail to request additional information on administrative forms, as well as to seek clarification on the statistical analysis discussion of the cervical osteoarthritis (COA) clinical summary. On December 13, 2019 our R&D team held a conference call with the FDA review team to seek guidance on the responses expected from the Company. The call was very encouraging, and we feel confident in our ability to send the required responses early this week.
Additionally, we were informed that the application has moved into the “Interactive Review” stage of the review, where interactions with the FDA review team take place more frequently and is the final stage before a decision is made on the application. Historically, the Interactive Review stage of the FDA has proceeded relatively quickly when compared to the “Substantive Review” stage.
<<< The move to an 'Interactive Review' was the first 'Heads Up' that BIEL's Full Body 510k was going to be Cleared. The 'Substantive Review' involves evaluating all of the data presented in the 510k, anything that would cause a denial is found in this stage. If an application makes it into 'Interactive Review' it is all about some minor changes, clarifications, and negotiating 'Labeling'.>>>
Recent BIEL Investor Updates relating to FDA:
1/20/2020 - FDA On-site Quality Audit
On Tuesday, January 14 the U.S. FDA conducted a quality systems audit at the Company’s manufacturing site in Frederick, Maryland. The two-day audit went smoothly, and no deviations/observations were identified in the Company’s quality management system. Additionally, the FDA provided several recommendations on how to continuously improve quality management and ensure global compliance, given that the Company’s products are exported to distributors in several continents such as MundiPharma SEA, and other potential distributors in Russia, South Africa and Ukraine with whom discussions are ongoing. Note that while the Company uses the distributor model internationally, an OEM-channel partner approach is being utilized within the United States.
The FDA periodically conducts on-site audits for registered medical device manufacturers to ensure that the manufacturing and distribution processes are compliant with federal regulations. The last FDA on-site audit for the Company took place in 2015.
<<< This Audit could have coincidentally occurred at the same time the 510k was close to Approval but odds are they are related>>>
******************************************************************
1/6/2020 - FDA Musculoskeletal Pain 510(k) Status Update
On January 3, 2020 the FDA requested a clarification of language on the labeling for our proposed indication for use (adjunctive treatment of musculoskeletal pain). We provided the FDA with this information on the same day. Additionally, we were notified that the FDA review team was evaluating the reports of our Electrical/Electromagnetic standards testing, and that they did not foresee any other concerns with the other portions of the submission that were not already interactively discussed. A final decision on our application is expected to be made prior to February 2, 2020 (90-day review mark).
<<<When the FDA starts asking questions about Labeling regarding a 510k it is time to Chill the Champagne as Labeling is irrelevant if the application is going to be denied. The FDA has taken a lot of Heat from Congress for delays in approving new medical technology. They take their 90 Day 510k Decision Goal very seriously>>>
*******************************************************************
12/16/2019 - FDA Musculoskeletal Pain 510(k) Status
On December 11, 2019 the lead FDA reviewer of our 510(k) application contacted us via e-mail to request additional information on administrative forms, as well as to seek clarification on the statistical analysis discussion of the cervical osteoarthritis (COA) clinical summary. On December 13, 2019 our R&D team held a conference call with the FDA review team to seek guidance on the responses expected from the Company. The call was very encouraging, and we feel confident in our ability to send the required responses early this week.
Additionally, we were informed that the application has moved into the “Interactive Review” stage of the review, where interactions with the FDA review team take place more frequently and is the final stage before a decision is made on the application. Historically, the Interactive Review stage of the FDA has proceeded relatively quickly when compared to the “Substantive Review” stage.
<<< The move to an 'Interactive Review' was the first 'Heads Up' that BIEL's Full Body 510k was going to be Cleared. The 'Substantive Review' involves evaluating all of the data presented in the 510k, anything that would cause a denial is found in this stage. If an application makes it into 'Interactive Review' it is all about some minor changes, clarifications, and negotiating 'Labeling'.>>>
