Replies to post #86140 on Bioelectronics Corp (BIEL)

[stallion70]

Nice!

[Gramps]

Excellent Simps.

[DewmBoom]

Wow. This is an incredible piece of information. This deserves a sticky!!! I know that you like a double-tsunami and I keep mentioning Big Bang. Having said that, I am okay with both!!!! We are inching closer and closer to the finish line!

[Moke31]

Wow that is a great piece of info !!!!!!

[lizanne1890]

Great news Simpsonly thanks for sharing!

[art2426]

From your conversation:
"he has stated that the reason they need further data was because musculoskeletal is a much broader application than what was applied for and its intended to expand the indication"

From PR:
"The agency has requested clinical data from an additional anatomical application area."

Ok let's see, now this is making all the sense in the world and these two statements seem to coincide with each other to what might be desired by the FDA to FINALLY get its stamp of approval. Seems to me they are looking for a little more proof/evidence on another part of the anatomy that the product can be a treatment for. What part is anyone's guess. But if they get that information, it seems like they have got what they need to cover all the applicable areas of use for the product. And as what my thought was previously, it looks like that they (FDA) want to give ONE big approval for this broad scope of usage instead of reviewing and approving different parts of body individually. This makes a helluva lot of sense to me. If this is the case, it looks like we are the verge of getting OK and it just might not be "FDA CLEARANCE, it could be "FDA APPROVAL"! NOW that would be nice to see STAMPED on every product package ---- a HUGE BONUS.

Now the question would be, "what is the other part of the anatomy we (FDA) are looking for??"

[DewmBoom]

Brilliant news. This is incredible. It's going to be a true Big Bang!!!!

[RVC]

Too-vague-to-be-actionable-as-usual

That's the business model strategy, be optimistic enough to help stimulate TOXIC sale of stocks, yet vague enough to not be accountable to anything definitive.

IE: We see no reason to not have clearance by end of year 2015
Which should not be confused with we will have clearance by end of the year 2015

Read the post closely and pull key words, these all are specifically intended to remove any "accountability"
"Hopefully"
"intended"
"soon"
"close"
"would"


"Concerning FDA clearance for Actipatch from my conversation with Andy. Hopefully this clarifies some of the concerns regarding their concerns; He was very easy to contact and pleasant to talk to. I asked him about the FDA, Ibex, dilution and sales. He stated that the FDA requested more clinical data, which BIEL provided this week. He stated that the reason they needed further data was because musculoskeletal use is a much broader application than what was applied for and it is intended to expand the indication. The 510(k) pathway to clearance is alive and well. There will be a press release from BIEL giving us an update on some of these matters soon. There is more info to be presented regarding Ibex. He couldn't say much more about it. He also stated they are close to not having to dilute any more. Sales are expected to increase with the new store additions. He said with FDA clearance in the USA it would take four to six weeks to have product to supply Walgreens and any other stores that would stock ActiPatch. He also stated there are continuing studies for bladder related issues." Soon

[DewmBoom]

I like this part:

"He also stated they are close to not having to dilute any more. Sales are expected to increase with the new store additions. He said with FDA clearance in the USA it would take four to six weeks to have product to supply Walgreens and any other stores that would stock ActiPatch. He also stated there are continuing studies for bladder related issues."