I checked with Gemini yesterday regarding the Complaint Files issue and it confirmed Chanel5's post 8216. This was also confirmed by a poster from another board:
" BIEL paid their annual FDA registration and added "Maintains complaint files" to the definition of their "Establishment." They are telling the FDA that they "Maintain complaint files as required under 21 CFR 820.198"
https://www.fda.gov/medical-devices/device-re...nd-pay-fee
Any Establishment that calls itself a "Manufacturer" has to maintain complaint files. BIEL probably received a complaint, so they have to maintain a file.
https://www.ecfr.gov/current/title-21/chapter...on-820.198
But it's probably nothing of consequence . It could be a complaint about packaging, or labeling, or even the color of the light. It could also be a complaint about efficacy, but this Establishment type designation by itself is not going to stop BIEL from operating, or selling, or anything else ."
Ironically, this same poster, who is a BIEL basher, has actually posted some recent detailed accounting information which matches my analysis and supports my projections that:
1) $800k annual revenue is a significant increase from the the $700k-ish reported the previous two years and will get the pps out of the trips;
2) $1.5 million annual revenue (or a $400k quarter) achieves cash flow positive/profitability and gets the pps to copper.
For reference, the three posts (an argument between two bashers which actually provides the data showing how close BIEL is to profitability) follow:
Post #1:
Positives for BIEL:
1. It's a real company with a real product.
2. The company is not burning $$$ millions every quarter trying to get a product through the FDA wringer. They accomplished that already.
3. The company is very close to profitability every quarter. Just a stone's throw, really.
4. There is no toxic debt. The company is not sinking under death spiral financing.
Down here in the world of sub-penny pink biotech, EACH of these is the exception, not the rule. That makes BIEL.... exceptional!
Post #2:
1. Yes, it is a real company. That quote has nothing to do with profitability.
2. The quote isn't "The company is not burning money every quarter." The quote is "The company is not burning $$$ millions every quarter" and it's important to keep that in context by including the phrase "trying to get a product through the FDA wringer." Also, "accumulated deficit" has nothing to do with the quote. Every biotech has an accumulated deficit during their developmental stage. This quote is about current burn rate. Think about it: $219,999 in 2023 for Other Gen and Admin Expenses -- FOR THE ENTIRE YEAR. That's bare bones.
3. Nobody said they are CLOSER to profitability. The quote is "they are close to profitability" and it's true -- they are. Expenses are bare bones at $750,000 a year. A popcorn stand has higher expenses. That's the common definition of profitability: Net Revenues exceeding Total Gen and Admin expenses. Debt isn't counted. Granted, at this bare bones operational level with one Officer, one guy in the warehouse, and nobody doing marketing or advertising, they will never generate enough revenues to pay off the debt, but that's not what "profitability" is about in this context.
4. You apparently don't know what "toxic debt" is. Look it up, along with "death spiral financing."
Post #3:
1. Redefinition fallacy. you're trying to redefine the phrase "real company" to mean "profitable company" and that's absurd to anyone who has done D&D on pinksheet frauds and scams.
2. A quote is a quote. Debate a quote literally or don't debate that quote. And yes, "developmental stage" -- most of that $39M accumulated deficit was incurred before 2020. They're no longer increasing that number by $$$ millions per year.
3. Red herring fallacy and redefinition fallacy. Yes, $750,000 per year those are bare bones expenses for GENERAL AND ADMIN EXPENSES (salaries, utilities, R&D, Advertising, etc). Those are not expenses for SALES -- expenses for sales go under "Cost of Goods Sold" on the Statement of Operations.
4. You still don't know what "toxic debt" and "death spiral financing" mean. Redefinition fallacy again.
" BIEL paid their annual FDA registration and added "Maintains complaint files" to the definition of their "Establishment." They are telling the FDA that they "Maintain complaint files as required under 21 CFR 820.198"
https://www.fda.gov/medical-devices/device-re...nd-pay-fee
Any Establishment that calls itself a "Manufacturer" has to maintain complaint files. BIEL probably received a complaint, so they have to maintain a file.
https://www.ecfr.gov/current/title-21/chapter...on-820.198
But it's probably nothing of consequence . It could be a complaint about packaging, or labeling, or even the color of the light. It could also be a complaint about efficacy, but this Establishment type designation by itself is not going to stop BIEL from operating, or selling, or anything else ."
Ironically, this same poster, who is a BIEL basher, has actually posted some recent detailed accounting information which matches my analysis and supports my projections that:
1) $800k annual revenue is a significant increase from the the $700k-ish reported the previous two years and will get the pps out of the trips;
2) $1.5 million annual revenue (or a $400k quarter) achieves cash flow positive/profitability and gets the pps to copper.
For reference, the three posts (an argument between two bashers which actually provides the data showing how close BIEL is to profitability) follow:
Post #1:
Positives for BIEL:
1. It's a real company with a real product.
2. The company is not burning $$$ millions every quarter trying to get a product through the FDA wringer. They accomplished that already.
3. The company is very close to profitability every quarter. Just a stone's throw, really.
4. There is no toxic debt. The company is not sinking under death spiral financing.
Down here in the world of sub-penny pink biotech, EACH of these is the exception, not the rule. That makes BIEL.... exceptional!
Post #2:
1. Yes, it is a real company. That quote has nothing to do with profitability.
2. The quote isn't "The company is not burning money every quarter." The quote is "The company is not burning $$$ millions every quarter" and it's important to keep that in context by including the phrase "trying to get a product through the FDA wringer." Also, "accumulated deficit" has nothing to do with the quote. Every biotech has an accumulated deficit during their developmental stage. This quote is about current burn rate. Think about it: $219,999 in 2023 for Other Gen and Admin Expenses -- FOR THE ENTIRE YEAR. That's bare bones.
3. Nobody said they are CLOSER to profitability. The quote is "they are close to profitability" and it's true -- they are. Expenses are bare bones at $750,000 a year. A popcorn stand has higher expenses. That's the common definition of profitability: Net Revenues exceeding Total Gen and Admin expenses. Debt isn't counted. Granted, at this bare bones operational level with one Officer, one guy in the warehouse, and nobody doing marketing or advertising, they will never generate enough revenues to pay off the debt, but that's not what "profitability" is about in this context.
4. You apparently don't know what "toxic debt" is. Look it up, along with "death spiral financing."
Post #3:
1. Redefinition fallacy. you're trying to redefine the phrase "real company" to mean "profitable company" and that's absurd to anyone who has done D&D on pinksheet frauds and scams.
2. A quote is a quote. Debate a quote literally or don't debate that quote. And yes, "developmental stage" -- most of that $39M accumulated deficit was incurred before 2020. They're no longer increasing that number by $$$ millions per year.
3. Red herring fallacy and redefinition fallacy. Yes, $750,000 per year those are bare bones expenses for GENERAL AND ADMIN EXPENSES (salaries, utilities, R&D, Advertising, etc). Those are not expenses for SALES -- expenses for sales go under "Cost of Goods Sold" on the Statement of Operations.
4. You still don't know what "toxic debt" and "death spiral financing" mean. Redefinition fallacy again.
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