Replies to post #16729 on Bioelectronics Corp (BIEL)

[imrichbeotch]

Couldn't have said it better!

Thanks

[stckdytrdr]

If you call and ask for Andy, he will answer all of your questions...I spoke to him yesterday, and was on the phone with him longer than I would have thought he'd have time for...colorofmoney is correct when he says Andy is open to taking investors calls...glta

[GoldenBull]

Hey investordisciple, you're right, it is not a useless discussion when understanding the FDA process to grasp a possbile timeline. I hope you and imrichbeotch aren't offended as that was definitely not my intention.

Now, what I am trying to say is while this provides investors an idea of when we could hear a response, but shouldn't we also focus and demand answers from BIEL managements on Dr.Scholls updates, Canada/UK launch updates, BIEL/Greenwood marketing group updates... issues of that nature that BIEL and its management has control over.

Also, the reason why I think Andy wasn't willing to answer investordisciple's question of what BIEL's FDA consultant had discussed with the FDA is perhaps Andy fears that we aren't true BIEL investors calling him, but rather someone from other medical devices companies posting as BIEL investors to try and understand BIEL's progress with the FDA? I am not talking about conspiracy theory, but just a thought that Andy is being protective of BIEL.

By the way, imrichbeotch, there is no need to stop posting haha. You've been providing great info for BIEL for a while. Plus, I wouldn't recommend putting your posting rights on the line for Andy's reputation, or are you thinking to sell your BIEL shares if investors don't hear anything by the second week of November lol.

[Dubb10]

The full (updated) De Novo process to reflect recent changes is here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm273902.htm

It is good for investors to be aware of the review cycles in order to have an idea of when the FDA should have contacted a company. Knowing such information can help investors create an exit plan if needed, or throw up a caution flag in case they are thinking about throwing more money at a stock. If it is a penny stock with limited or no revenue, they may be throwing money at a stock that could end up getting diluted and forcing them to lose more money. Unfortunately, the FDA only posts clearances/approvals, and it's up to the individual companies to keep investors informed. For newbies, asking the FDA for an update will not get you anywhere because they will tell you to contact the company. This can put investors at a disadvantage since they may be kept in the dark. I'm not saying this is the case with Biel.

Example 1: When I first started investing in Pharmas a few years ago, one particular company was waiting on a decision from the FDA on one of their drugs. Time passed, and every time investors asked the CEO, he simply said that they were still waiting on a decision from the FDA. The stock rose, then unexpectedly dropped one day. Still no press release stating the FDA's decision. Turns out that the FDA had issued a CRL and listed some serious concerns; however, the CEO didn't acknowledge any of this information until months later. I forget how information of the CRL was discovered. Investors later ended up suing the company. That stock is now trading at 6% of what it was worth back when I first got into it, and they are still waiting on FDA approval. The issues that were raised are still being addressed by the company.

Example 2: More recently, a CEO kept putting out PR's that were sent to all the major financial sites stating that the FDA decision on a 510(k) application could occur at any time and that he was confident in a clearance. He said he felt all the necessary issues were addressed. Within the 90 day cycle time for the review, he posted an update on OTC Markets (Pinksheets)that the FDA issued a NSE letter. He didn't post a PR that was release to various financial sites. Legal but a little sneaky of him. The investors were notified on various boards, but some are still holding out hope.