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5. Action on a 30-Day Notice, 135-Day PMA Supplement, or 75-Day HDE Supplement
If the change qualifies for a 30-day notice and you have submitted complete information in the 30-day notice to FDA, you may distribute the device 30 days after the date on which FDA received the notice, unless FDA notifies you with those 30 days that the notice is inadequate.
However, if the information you have submitted is not adequate, within 30 days of receipt FDA will inform you in writing that a 135-day PMA supplement (or for HDE holders, a 75-day HDE supplement) is needed and shall describe additional information or action that is required for acceptance of that change. 21 CFR 814.39(f), 814.108.
If no action occurs within 30 days of receipt of your 30-day notice and payment of the user fee, you may distribute the device without further action from FDA.12
From the FDA website
It is fun reading these comments of people so worried about these small losses. News is coming but this will not move until then and you will keep seeing days like this so just watch and wait.
There is nothing to be concerned about. They fixed it. If anything this is a great sign.
Calm down there. That is just a pump website. She is 90% wrong
Very smart trading.
You your probably right there. It may be phase 2 I was thinking of which I know its a lot higher price per person
10 patients. Each pt usually cost 120000-180000 so it is not cheap. I used to have the DD on it but lost that. I will try to find it to show proof
I have a lot invested into Koos and believe he will get the job done. Once we get the news this will never see trips again. Probably never see double zero again for that matter. This will see a penny this year I have full faith into that but I think we should see a penny by July but that is just a feeling.
Which is why I keep buying at these levels
To begin human trials they stated July and they are behind which I may still happen but I feel we will see other news before that which will sky rocket this up even before the trials begin.
I agree that is the catalyst we need but will not get much anywhere until then. Over 12 million strong.
Whoever is here should know that we need a catalyst here to get the day traders and shorts out here. That is what has been hurting us lately I feel. There is no dilution going on here. The thing is once we get news then .005 is laughable and something you will never see again just due to market value alone will keep this in the pennys and above. But nobody can actually say when this news will come. Could be June July August nobody knows here but don't expect much until news gets drop. You probably will see a big change a day or two before the news get dropped due to insider information getting leaked out but again we will not see a real run until then. People here are upset over a small red day just shows that they are here for short term and know nothing about what they are investing in. Either way when I say I am here long I am her long. Been here for over 2 years now and we are getting closer each day till the news we most of us all been waiting for. Good luck longs here.
GO BMSN/REGEN/ENTB!!!!( Don't forget ENTB)
I know I agree with that expect that gaps here are pretty large making it even hard to sell at the bid. This stock trades different than most I have seen
I still believe in this company but I don't blame people in selling here. I was promised that mid may that the 10 k will be released and look were we are at. I understand there are set backs but this is starting to be not a good sign here. Again not bashing but don't tell people they are dumb for selling. With each day it was gets more risky to hold on and everyone has there own limits.
Good close just need to keep chewing away at the 7s
Huge big but huge ask right now. Somebody wants to keep loading before the big run
Well today was a huge day closing at .004. Tomorrow should be a strong day.
With sister company moving like it is cam be a nice sign of what is ahead. We will be moving fast here soon enough. This will be a solid run coming.
Great day today. I like seeing big sisters movement today. It will make our run that much stronger. Buy now while you can at these prices.
You know I always thought it was interesting that he gave the exact date of when he submitting changes the FDA wanted. Koos did not have to give us the exact date.
On May 9, 2014 the Company updated its IND with changes requested by the FDA and submitted them for review.
I am thinking we are going to see news soon.
If anyone has doubts with buying right now all you got to do is look at the charts. Going to want into this one. Should be getting out of the trips this week again and if we see news then we will never see trips again.
Nice bid support with ask going down in size is good to see
Took a while for me to pick up my fill of 6s today but I got them. Anyone to get 5s ad 6s are should feel lucky to have. The PPS will be changing here soon I know and it will be a life changer
Love it! Copper coming soon
Epic update here. This is going to fly!! Unless we see a AS increase he can not dilute much and he will not do a r/s. He does not believe in them.
What rumors
Good support here. I am loading....Penny easy here when the big news gets dropped
Just curious why you say 3 weeks?
I was thinking the same.
I see a lot more buying than selling here. A lot of hidden shares seems to me to try to push this down.
Charts are not ready yet for the big move to penny yet. I do feel we will see 5s and possible 4s before we move unless we get a big catalyst to change momentum which this golden cross I kept hearing is not going to help us. Going to take real news I feel. So we need to start making a good base which I feel will be at .0005 and possible .0004 or we get big news. After either one of those happen we then can move north again.
When I talked to Steve and he said that he knows that he has to be over a penny by the end of May due to the new OTC QB rules and he believes there will be no issue getting there with the news he has going out of which he could not speak of due to legal reasons. I am thinking we will see the reduction of AS in may and that will bring it to a penny with no issue when that becomes official.
From doing research on new ipo a range of how long it takes to release the ipo is 15-150 days but there is no set time of releasing they say for releasing it.
Great update!!
A lot of companies are using mmj cpanies for pump and dumps and the sec has really started cracking down on these companies so I rather stay away from the mmj sector right now
So you don't understand how the sec filing works here but let me help you. They did not stop disclosing they are late with there 10k. Happens all the time and they will become current once they release the 10k which will be less than 2 weeks away. They just have yo file 30 days after the due date. Sorry to burst your bubble but just do a little more research on the sec rules before posting please.
Just rumor that was made up on this board.
Bmsn owns a large portion of entb. The value of entb is very low and same goes for bmsn. So this means when all the news gets released for the new IPO other news expected for bmsn will greatly increase the value of bmsn which will increase the value of entb and with the lower share structure should make a huge change in pps here. This is going to be huge I feel but the only issue is when all this news gets dropped
There are people here estimating 3 weeks and not sure how they pulled that number from but one can hope but likely take longer than that.
Not sure why people keep asking this question but it is not known yet. But here is a good read to help you
There's no set time for an IPO
Q: How long does it take, on average, for a company's IPO shares to begin trading after they file with the SEC?
A: When a company decides it wants to make an initial public offering (IPO) of stock and "go public," it can't just go out and start collecting investors' money.
There's a process, which is highly regulated, that guides companies through the steps. The first step, as you describe in your question, is filing a registration statement with the U.S. Securities and Exchange Commission (SEC). This is where the company completes a usually lengthy document, called the prospectus, which explains all the details about its operations, the risks it faces and why it is looking to tap the public market. This document is important because it is really investors' only source of information on the company. And in many cases, these documents will be the first time investors have gotten a close look at a private company's inner workings.
But it's not enough to just file your registration information. The SEC will then look over the prospectus and make sure all the important information is disclosed fully. In some cases, regulators will ask the company to include information that's missing. Only after satisfying the questions from the SEC can the company go forward with its IPO and sell shares to the public.
How long does it usually take for a company to get its registration statement approved and begin selling shares? That depends on how many questions regulators have about the company's registration statement. It also depends on how many companies are going public.
When there is a flurry of IPO activity, the approval process slows down. The time can be as little as a few months to as much as six months. And just because a company files to go public doesn't mean it will. Sometimes a company postpones or withdraws its IPO after filing.
To give you an idea of the time between filing the registration papers and going public, below are some recent examples:
HOW LONG DOES IT TAKE?
Company (ticker) Date filed Date trading began Number of days
Chipotle Mexican Grill (CMG) 10/25/2005 1/26/2006 93
Altus Pharmaceuticals (ALTU) 10/17/2005 1/26/2006 101
Calumet Specialty Products (CLMT) 10/7/2005 1/26/2006 111
Traffic.com (TRFC) 8/31/2005 1/25/2006 147
American Railcar (ARII) 9/8/2005 1/20/2006 134
Western Refining (WNR) 9/27/2005 1/19/2006 114
Linn Energy (LINE) 9/19/2005 1/13/2006 116
Nucryst Pharmaceuticals (NCST) 12/2/2005 12/22/2005 20
CRM Holdings (CRMH) 9/19/2005 12/21/2005 93
PixelPlus (PXPL) 12/5/2005 12/21/2005 16
Source: Renaissance Capital
So it looks like 16-147 days or more it can take to release a IPO. So have patience it will be coming