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Bid x Ask building. Looking like it's getting ready to move back up again.
Bid growing nicely here! Liking this LVGI action! Wish I had more shares!
MMs fishing for shares on this dip. Will head back up EOD, imo.
EXACTLY! Link back to my previous 3-4 posts helping provide DD reinforcing your DD.
It's a done deal, approval is in the BAG! Just a matter of MFST receiving the letter and providing a PR of such.
The FDA made the "Substantially Equivalent" decision last Friday (7/8) and today is Wednesday (7/13). The company must receive the Letter in the mail from the FDA officially stating that SE has been granted. That letter should be arriving today thru Friday of this week (anytime now). Once received MFST has the green light to market their laser product in the US.
From the FDA:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm#se
The MFST device has received a "Substantial Equivalence" decision from the FDA. Here is an explanation of what "Substantial Equivalence" is (pay attention to BOLD phrase at bottom):
What is Substantial Equivalence
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
A device is substantially equivalent if, in comparison to a predicate it:
• has the same intended use as the predicate; and
• has the same technological characteristics as the predicate;
or
• has the same intended use as the predicate; and
• has different technological characteristics and the information submitted to FDA; ?does not raise new questions of safety and effectiveness; and
?demonstrates that the device is at least as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
A device may not be marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:
• resubmit another 510(k) with new data,
• request a Class I or II designation through the de novo process
• file a reclassification petition, or
• submit a premarket approval application (PMA).
It's quite possible since this decision just occurred on 7/8/2016 that MFST has not received the LETTER from the FDA yet. Once they receive the letter I'm sure we'll get a PR from the company. Have a nice day!
You're going on Ignore. I've provided all the links you need to educate yourself and you refuse to do so. F Off!
Yes, that is correct. And we can now start to make more $$$.
Read up on the what "Substantially Equivalent" and "Pre-Market Release" mean. You're treating the MFST device as though it's a totally brand new novel device. It's not, it's just better than other similar devices on the market.
Further, they initially filed the 510(K) on August 28, 2015. The FDA provided a full review then and asked for more data/information. MFST conducted more clinical trials/experiments and provided the supplemental data June 26, 2016. The FDA had already reviewed the bulk of the 510(K) filing so it really just had to focus on the supplemental data. They made their decision on 7/8/2016 that the device is Substantially Equivalent to another device that is already approved for the market.
That's it! End of story! It can be sold in the US now.
Correct!
And here are all the links that anyone needs to follow to find the same information and read up on FDA's explanation of the meaning of SESE.
MFST have received pre-market notification:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152461
If you want to do the Search yourself, go to this page and search on the 510(K) number (K152461).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
Further, you should study this page and all the answers it provides. You will come to the conclusion that the MFST laser device is now released for sales on the market.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
Here's your proof:
MFST have received pre-market notification:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152461
If you want to do the Search yourself, go to this page and search on the 510(K) number (K152461).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
Further, you should study this page and all the answers it provides. You will come to the conclusion that the MFST laser device is now released for sales on the market.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
The July 2016 Devices Cleared list has not been published yet.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm483517.htm
The MFST device was cleared on July 6th. Won't be in the part of the website you're looking in until August.
Best,
TP
Well of course! He's not going to give you insider information!! Sit on the sidelines with your thumb in your mouth while we make $$$
BINGO!!!
"Substantially Equivalent" is as good as approved. "Approval" is pretty much an administrative event now.
KABOOMAGE COMING!!
We're cookin with GAS now!!! WEEEEEEEE
This has tightened right up. Looking to run now!
MAKE THIS POST I'M REPLYING TO A STICKIE!
WOW! That's IT! "SUBSTANTIALLY EQUIVALENT"
We're BIG TIME folks!!
And if one should be so inclined, after the FDA approval update it will be about Distribution partnership updates for marketing and sales.
IMPORTANT DD: 510(K) Supplemental Data
I see some folks here are treating the June 26, 2016 510K submission to the FDA as though it's their initial submission and thus it will take 90+ days to get a response from the FDA.
This is not true. The initial submission of the 510(K) application occurred August 28, 2015 and was fully reviewed by the FDA. You can find that here: http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=10907827
After a complete review of the 510(K) submission the FDA requested further data from the company to supplement the submission so they could make a valid decision on whether to approve the application. The company then went out and conducted further clinical trials and experiments this past Winter/Spring. The June 26, 2016 submission was the re-submission of the 510(K) plus all of the supplemental data they were asked to provide.
Ergo, the bulk of the 510(K) application has already been reviewed by the FDA and their focus on this review will be the supplemental data, which should not take 90 days.
Things will move faster than some believe, IMO.
BIG TIME! MACD will give us quite a bit more movement north too. This is going to ROCK!!
Strong close! I think we'll see more tomorrow.
Something like that would have to be pre-planned by an MM who'd be gathering inventory to close the transaction. Or, they just naked shorted it and created the share out of thin air. LOL, nothing would surprise me.
That's anything over 5% ownership, isn't it?
That's great news! Thanks for posting!
Alcohol products are a great place to be during market chaos and down-turns. Everyone drinks, in good times and bad.
$SLAM will bring the $$$
Gotcha, thanks for the explanation!
Oh mine went all red for a couple minutes (to calm things down), now it's flipped back to all green. The red was in the same 100 and 300 share blocks as all the buying today. I think they did it just to shake some nervous shares out but they're buying again now.
Check L2 now. Someone flipped the switch! LOL, how does the SEC not see this stuff?
Wow, the ticker tape tells the story. HFT in action here, for one of the reasons you listed.
It's a very controlled ascension. Looks like Hedge Fund(s) with pals that are MMs.
Looks like a buyer wants to take a substantial position without running the price up. Probably someone big who's using a High Frequency Trading algorithm to process all the transactions.
JMHO
Not the time to sell, imo. This is just the beginning. Getting out of the trip 000s is always the hardest part, but also the most rewarding.
JMHO
GO $LVGI!!!
Only 9.6 mil shares on the ask (.0005) and we're moving right through that this morning. $LVGI
The Hunt for the Next 10 Bagger board has been alerted. Keep up the good work, get the word out there. Provide the URL to the news wherever possible. Thanks!
http://www.marketwired.com/press-release/slam-colas-are-approved-otc-pink-lvgi-2135693.htm
LVGI looking for a possible penny run. 10 Bagger+ potential. Ask about to fall... News out this morning:
http://www.marketwired.com/press-release/slam-colas-are-approved-otc-pink-lvgi-2135693.htm
LVGI about to make a move. Ask falling!
This is what we've all been waiting for. Blue sky is almost in sight. Keep getting the word out!
I've heard that. They'll moving on to the 2nd batch pretty quick I think.