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One more tick south and I’m a buyer!
In theory, exactly 60 days
As of 14 Sep they have asked questions. That may narrow the timeline to repack the 60 day clock. That would but us at mid-Nov for approval...
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Yes. Additional information is always part of the process.
Paul Knopick
---------- Forwarded message ---------
From: Vapor09 <>
Date: Fri, Sep 14, 2018 at 3:57 PM
Subject: Information Request
To: <info@bielcorp.com>
Hello,
I am a shareholder and would like to know if the FDA has requested any additional information on the Actipatch 510(k) submitted in July.
A simple yes or no will suffice.
Respectfully,
I asked, and questions were asked. See below. As of right now I believe BIEL is a solid investment, but the timing is out the window. Buy what you are comfortable with and hold till FDA approval.
————————-
Yes. Additional information is always part of the process.
Paul Knopick
---------- Forwarded message ---------
From: Vapor09 <>
Date: Fri, Sep 14, 2018 at 3:57 PM
Subject: Information Request
To: <info@bielcorp.com>
Hello,
I am a shareholder and would like to know if the FDA has requested any additional information on the Actipatch 510(k) submitted in July.
A simple yes or no will suffice.
Respectfully,
That’s cool!
I think Friday, that would cause flippers to hold the weekend and keep the PPS from dipping on the Friday sell off. Folks doing DD over the weekend see the news and buy Monday morning. All a perfect storm, and never how it happens... LOL
Could this Friday finally be “The Friday”?
I think one penny would be huge
Valid
LOL! Scathing and brutal, but true. Way to get it noticed and killed.
Creeping north... when does the news hit? How high do we go?
Agree! Two, potentially large, press releases looming. If both drop together or in quick succession, LIFT OFF!
Well done, very good news!
From the below correspondence, in my opinion, we are in a purgatory with regards to timeline. If info was requested since July, the time line for approval has slipped later. Again, my opinion and research, not a professional investor by any means.
Yes. Additional information is always part of the process.
Paul Knopick
---------- Forwarded message ---------
From: Vapor09 <>
Date: Fri, Sep 14, 2018 at 3:57 PM
Subject: Information Request
To: <info@bielcorp.com>
Hello,
I am a shareholder and would like to know if the FDA has requested any additional information on the Actipatch 510(k) submitted in July.
A simple yes or no will suffice.
I have done enough DD on the FDA process and talked to folks in the medical device community who are familiar with the process to understand it is not as simple a “in 60 or 90 days” Biel will have approval. All the FDA has to do is ask one question on the 510(k) and the timeline resets. If BIEL does not communicate that to the shareholders, we no longer know where we stand on the timeline. My guess/feeling is this will not happen, so either it is approved and announced in the next week or two, or it is not approved and the company make no announcement and the stock begins to drop.
If not, we are in no man’s land on the information release. Company must give some kind of update to either keep the price stable, or launch it into the stratosphere. No news is bad news in this case.
Sorry, let me rephrase that... less likely to be approved at all.
Any day after today for announcement. Unfortunately, the longer it goes without an announcement, the more likely it is still not approved.
I hope we hear something tomorrow.
There is a reason why “wait” and “accumulate” rhyme... :)
If we are past 60 days, and I agree we are there or close, we need to know if there were any questions asked by the FDA. If no questions, then we are home free. If there were, the app has been “held” till answers are given, then the 60’day starts again.
I will have to check, but the FDA has 60 days from the day of submission, not when the “get to it”. The clock is running, unless questions were asked, then the 60 days is reset once the answers are provided. If no questions are asked, it is either a “yes” or “no”.
I talked at length with him, and he is quite knowledgeable and built his business on this routine.
60 days
I’ve discussed this with someone who owns a medical device company and deals with these submissions daily. It 60 days with approval, or greater than 60 days with questions and the timeline resets with every separate set of questions.
FDA questions are not bad, but if the company does not communicate that questions have been asked, we can only assume that the 510k was kicked back with no approval.
I anticipate approval...
I am hoping for late next week, early the following.
60, not 90
FDA approval takes 60 days on a 510 if the FDA has “no questions”. If there are none, Actipatch is approved sometime next week by FDA and we should get an immediate press release. If the FDA has questions, at anytime during the 60 days, the 60 day clock restarts. So, if there are/were questions and the company does not inform the shareholders, we are in no man’s land with regard to the timing. Then you have to ask, why were the shareholders not informed there were questions... another concern.
This Friday, 14 Sep will be the earliest we hear anything from the FDA. If we move through next week without words, I will be highly concerned.
Either 14 or 21 Sep we receive Words from FDA, only if follow on questions were asked.
Agree, .003 is a profit taking zone.
Words from either FDA or BIEL by mid month, call it week of 17 Sep. if we here nothing, it means the FDA has asked questions resetting the 60 day clock on approval. Every 30 days after that, with no communication from either, would be cause for concern.
The FDA review is not ten days late. The FDA has sixty days to ask questions, every question resets the sixty day clock. Soonest we will hear anything is mid September.
It sucks, but it is the way it works.
Have they tried Shark Tank?
They have 60 days to ask questions. Every question will reset the clock. If no questions by 12 Sep we are off and running.
Eventually, we will need a share but back program to make individual millionaires... until then, I’ll take a couple 10’000’s here and there.
510K is in a 60 day period awaiting further questions from FDA. If the 60 days expires without questions, then it’s time to like this candle.
Agree, about next six months.
If no questions from FDA on 510K by 12 Sep, we should be setting sale soon after with full clearance. FDA has the right to ask questions within 60 days of submission. Unfortunately, when they do ask a question, the clock resets once the answer is provided. I figure this will b ironed out by December, as nothing with the GOV is ever fast.