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BioElectronics Corporation Message Board

mtoronto48 10 posts  |  Last Activity: Sep 18, 2014 11:14 AM Member since: Oct 29, 2009
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  • Hi Everyone, This post is based on public information but I had contact with a certain person at the Agency to guide me through the process, it's not easy to find.

    There is no specific time for a final order to be issued.
    At this moment comments are being considered, responses to the comments and the final order itself are reliant on types of comments received and ongoing priorities.
    The FDA is aware that there is significant interest from manufacturers, patients and stakeholders in bringing this classification effort into a timely conclusion.

    Another item is that the FDA also proposes that 510k's be submitted withing 60 days of the effective date of the final order with special controls.
    The FDA is also requesting comments if 60 days is enough time. This action with comments will also prolong the effective date. I can't figure out why there is only a 60 window to submit on a new classification, still trying to find out.

    So while we are waiting for the partners, investors and hopefully Shoppers Drug Mart in Canada, follow the 515 Project Status page for updates.

    Please note that the FDA did not mention "New clinical trials" must be submitted only special controls. Certainly there would not be enough time anyways. That's a great thing.

    One more thing, if anybody has submitted a comment they would recieve a tracking number for confirmation as well to be used to search for an response to the comment.

    Trust his helps.

    Sentiment: Strong Buy

  • Reply to

    515 Project Status

    by mtoronto48 Aug 31, 2014 10:42 PM
    mtoronto48 mtoronto48 Sep 1, 2014 2:45 PM Flag

    Hi Coach, if you read some of the final orders or rules that were posted in 2013 and 2014 you will read that the final orders were posted about one year after the comment periods closed. Trust this helps.
    Yes, it could happen sooner, no doubt!

    Sentiment: Strong Buy

  • Reply to

    515 Project Status

    by mtoronto48 Aug 31, 2014 10:42 PM
    mtoronto48 mtoronto48 Sep 1, 2014 1:16 PM Flag

    Ri.leee, you better hope that Toronto does not win the bid on the Buffalo Bills, your Super Bowl may be ruined as well. Results in a few days. lol

    Sentiment: Strong Buy

  • mtoronto48 by mtoronto48 Aug 31, 2014 10:42 PM Flag

    Hi Everyone, reading through the FDA project status it looks like it could take at least another 8 months more or less for the final order. The FDA's past performance on re-classing products with other companies state just that. The 515 Project Status works in five steps, from A to E. The tasks completed to date by the FDA is at "D" which is that the FDA reviewed and considered the comments from the May 21st deadline for comments. I don't know why it takes so long but there is another step after this. The FDA will post the final order but will not publicly release the final order for at least two weeks. Futhermore, the FDA then states that the order will become effective usually about 5 weeks after the order is posted. Now keep in mind that this could all occurr earlier but the FDA is the FDA.
    I have no problem waiting on this considering we are waiting for great news in respect to partners, investors and new products coming out. This is BIEL's chance to prove what they can do during this wait to show all investors that they can succeed without the FDA.

    There will be so much going on in the next few months that I will not even attempt to guess what the pps will be upon FDA re-classification.
    Let's wait for the first bits of monster news coming out and other great things to happen as well.

    Have a nice holiday.

    Sentiment: Strong Buy

  • Reply to


    by mtoronto48 Aug 28, 2014 7:58 PM
    mtoronto48 mtoronto48 Aug 28, 2014 9:18 PM Flag

    Hi Super, looks like deals have been inked, so hopefully by end of September. There is usually a cooling off period for certain deals before they are announced.

    Sentiment: Strong Buy

  • mtoronto48 by mtoronto48 Aug 28, 2014 7:58 PM Flag

    Monster news coming out! There are too many big pharmas to say that Roche is one of the partners. Nothing wrong if they are one of them.
    BIEL is simply backing up their statement in the letter from the President saying that they will succeed without the FDA. The news item is about a big pharma buying a product from an American company that does not have FDA approval. Very similar with what's going on with BIEL, more or less selling rights and patents to big pharmas in Europe.

    Trust this helps.

    Sentiment: Strong Buy

  • Reply to

    Interview with Dee

    by mtoronto48 Aug 19, 2014 8:19 PM
    mtoronto48 mtoronto48 Aug 19, 2014 8:56 PM Flag

    Ri.leee, 4 partners and maybe more but do you think that Sanofi will take it well knowing that their product [Tens] is limited in pain therapy? Also keep in mind that there are more than just a few patents out there and more are coming!

    Sentiment: Strong Buy

  • mtoronto48 by mtoronto48 Aug 19, 2014 8:19 PM Flag

    It looks like at least 4 partners coming in as well as maybe 1 or 2 private investors. Keep in mind that there are other products which have not been mentioned yet. Here we go again waiting for the near future.

    Best to all.

    Sentiment: Strong Buy

  • mtoronto48 by mtoronto48 Aug 4, 2014 6:43 PM Flag

    Read the letter carefully and clearly. BIEL states that they will suceed without the FDA! Impending news will be out soon to clarify what makes Dee invaluable in respect to his negotiations with partners and investors.

    Trust this helps...................

    Sentiment: Strong Buy

  • mtoronto48 by mtoronto48 Jul 27, 2014 5:06 PM Flag

    It's been just over two months waiting so far for the final order to be posted. I trust that BIEL using this time to put together an excellent submission to be filed after the final order is posted. Last but not least, the company is also in negotiations with a North American Distributor as well as a large pharmacy chain. [Maybe more than one]
    I just don't see the company getting FDA clearance and then state that they need to find an distributor or pharmacy chain. It just doesn't work that way!

    BTW.............Hi Rilee

    Sentiment: Strong Buy

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