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@ValueGrowth20 I wish I could be as optimistic as you are. If they thought they were close to CE approval the optimal time to announce this offering would be AFTER the notice of approval; investors would be breaking down the door to get in on this. This offering is for general operating funds..looks to me like they are getting reading for a long wait.
The offering 3 months ago caused the stock to loose over 40% of it's value. And that $2.5M was peanuts compared to what they want now.
Not trying to be negative...but this doesn't look good to me!
@ValueGrowth20 I have also expressed my doubts about DBE several times on this forum. Products are distributed via wholesale distributors who will purchase quantities in advance and have established sales forces already in place servicing hundreds or thousands of locations.
DBE on the other hand is a little more of a "as seen on TV" kind of operation. They signed an agreement with Nemaura to distribute Sugarbeat under their own PRIVATE LABEL. Google their website, mysugarwatch. The website has been neglected and outdated for years, doesn't come across as someone ready to launch any day. They don't appear to be taking this seriously.
Also, again yesterday was something like 95% selling. I'm surprised the SP hasn't tanked. Just 3 or 4 months ago it would have lost 10-20% of it's value in one day. I'm just suggesting caution, especially over these final few days of Brexit uncertainty.
Is that April 12th extension a definite? Do the Brits have to approve it?
@warrenbettis That google term is magic, it did indeed reveal a bunch of companies that just received CE approval. Please continue to contribute to the forum as knowledge is power.
Back to basics: So today is Tuesday, Thursday is Brexit. What exactly is the impact of no agreement reached by Thursday?
There has been much talk of an extension but none negotiated yet, right?
I believe this is the third trading day in a row where the sellers vastly outnumber the buyers, buy a 3-1 margin....yet again the SP rises 3%.
@iddirsw Well? Are you going to leave us in suspense??? lol
Price Prediction...
SugarBeat is a much more desirable and affordable product than Dexcom, and Dexcom SP is at $129. today. Several months ago I predicted that Nemaura's SP would eventually be in the same ballpark, especially since they are debt free unlike Dexcom.
But due to Brexit we probably will not see the frequent SP rises as they get clearances to enter France, Germany, Spain, etc one at a time. Nemaura can pretty much write off most of Europe because of Brexit.
I'm going to predict about $8+ within 30-45 days of CE approval assuming immediate commercialization. Maybe $20 within 120 days as they get up to speed in the UK and Mideast. The major rise
will come upon FDA approval so lets hope the de Novo route is accepted.
I can see the possibility of $100 after a year as I believe Sugarbeat will be in huge demand among Type II's in the USA.
There evidently isn't any good news coming out of the shareholders meeting. They've had 9 hours to place buy orders on their cell phones and that isn't happening.
Let's hope we can get some kind of update soon.
@Whiskey 9am is 4am our time (Eastern). So hopefully we can get some early news.
Have we identified any of our forum Brit friends who are attending?
The shareholder meeting notification doesn't state a time, but the Brits are 5 hours ahead of us so hopefully we can get some kind of info before the market closes here or shortly thereafter.
Today was another one of those days where 16K shares were bought, 44k were sold yet the SP still went up 3.55%.
@WhiskeyBusiness I think his name is kind of offensive and makes his posts seem worse then they really are.
@iddrisw You read my mind about BSI, they do seem to have a monopoly on medical devices right now based on everything I've read. I too have suspected they have been deviating resources from pending cases to new clients. Not even accepting new clients. Does anyone know if BSI was their notified body when they were approved in 2016?
Today is the 20th. Brexit is on the 29th. I predict today starts the psychological "we're out of time" timeframe and SP nosedives barring any MAJOR news at the shareholders meeting. I can see SP going down into the .70's.
I actually got a response from the European Union regarding pending CE applications upon Brexit:
Thank you for contacting the Europe Direct Contact Centre.
If the draft Withdrawal Agreement agreed at negotiators’ level on 14 November 2018 and endorsed by the European Council on 24 November 2018 is ratified by both Parties, there will be a transitional period until at least end-2020, with a possible extension until end-2022, during which the UK will continue to be part of the EU Internal Market and Customs Union. This means that during the transitional period trade between the EU and the UK will continue on current terms. The regime applicable in bilateral trade after the transitional period would depend on the outcome of the negotiations on the EU-UK future relationship.
In the event of the UK leaving the EU without a ratified withdrawal agreement (“no-deal”) on 30 March at 00h00 CET (“withdrawal date”), both the European Commission and the UK Government have issued technical notices providing guidance to businesses in all relevant policy areas.
As regards regulatory requirements for placing goods on the UK market as of the withdrawal date in the event of no-deal, please refer in particular to the UK technical notice “Manufactured goods: requirements after Brexit” of 15 February 2019: https://www.gov.uk/government/publications/manufactured-goods-regulatory-requirements-after-brexit?utm_source=d09adcdc-c9fc-4c4d-ac73-e79dff6bad56&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate.
All information on Brexit preparedness on the EU side is centralised on the website of the European Commission’s Brexit Preparedness Group: https://ec.europa.eu/info/brexit/brexit-preparedness_en. CE-marked products are specifically addressed in the notice on industrial products of 22 January 2018 and the accompanying questions and answers of 1 February 2019, both available here: https://ec.europa.eu/info/brexit/brexit-preparedness/preparedness-notices_en#grow.
You can find more information about the ongoing Brexit negotiations at: https://ec.europa.eu/commission/brexit-negotiations_en
We hope you find this information useful. Please contact us again if you have other questions about the European Union, its activities or institutions.
@iddrsw Its ok with me. The lower it goes the better.
@Think If you think 97 cents is low you ain't seen nothing yet! Look for it to nose dive for the rest of the month due to the uncertainty of Brexit.
Again, good info iddrisw. Do you have an idea of how long the additional delay might be after migrating the files to BSI NL?
As far as the validity of the CE mark after Brexit goes they could still market to the UK and mideast, correct?
And curious as to whether you have an opinion as to whether CE Mark will be granted this month?
@iddrisw First of all thank you for the constructive criticism and the information. If I'm coming across as a little paranoid it's because I am now in the 9th month of "any day now"
My DD indicates BSI is a top notch company which is exactly why I'm a little concerned. When Chaz spends 9 months signaling "any day now" I have to assume he's getting this projection from BSI, which is in a position to know. And if BSI with all their expertise projected approval several months ago and nothing's happened is it not a cause for concern? Maybe an issue, maybe a backlog but why not an update from the company?
Oh, and any critique from me is just an attempt to brainstorm and stimulate conversation during these dog days.
@Think I'm not aware of any upcoming conference call, but we are now exactly one week away from the shareholders meeting. If nothing changes in the next few days that meeting ought to be as exciting as attending a funeral. Are any of our Brit friends going?
And no Think, there are no ADR fees for Nemaura.
In the Dec 21 Q&A video Chaz says the clinicals were completed and they were only waiting for the official sign off. He then goes on to say he expected the sign off in mid to late January. A delay from previously projected end of 2018.
End of 2018? Mid to late January? We are now heading into late March! There is obviously some kind of complication.
I am just wondering at what point are they legally obligated per SEC regulations to file a Form 8K and disclose what the complications are.
How low can it go??? Fridays are never good in slow periods.
@Think Nemaura has enough cash to last through the year. And even after that they can survive as they are the same officers as Nemaura Pharma.
As far as the FDA process goes that is still an expensive process which would eat up their cash quickly. They have already started the process for the De Novo submittal but I can't imagine them going any further at this point until CE approval.
Chaz was interviewed and quoted for that news release, yet blew a golden opportunity to to give us an update on CE approval.
Last update from Chaz was clinicals were completed and they were
awaiting the final sign off in December, then disappointed it wasn't received before December ended. It it now mid March!
Right now lets hope the UK votes for a two month extension on Brexit, and soon. And since the entire EU has to unanimously approve the extension lets hope everyone agrees.
Good info Maley. I cant get the chat box on their site.
I'm curious as to what kind of delay that BSI NL scenario might cause.
Can't ignore the steep drop, I just reduced my position by 60% and
might sell the rest tomorrow. This stock will continue to nosedive if no news and will become close to worthless on March 29. Despite the various theories they cannot get CE approval if they are not a member of the European Union, and they will not be a member in 3 weeks.
However I am sitting on the cash and monitoring the news looking for another entry point as I still believe in the product.
@Jreyes Based on the trading in the last few days I believe it's time to start liquidating some shares myself.
Good luck with your other investments!
@iddrsw You come up with some interesting stuff (the link and that SEC document).
However the amount of backlog BSI may have should be irrelevant as Chaz Chowdhury told us everything was done and all they were waiting for was the official CE sign off.
Unless he lied to us?
10,000 shares bought, 59,000 shares sold today.
@Whiskey I don't think it matters much about commercialization plans or FDA if there is no CE approval.
Six years of waiting have now come down to do or die in the next several days. While it is possible something might develop like a delayed Brexit I wouldn't gamble on it right now.
18 trading days left before scheduled Brexit. The first 76 trades today indicate the stock is still highly liquid.
We need to monitor the trading patterns closely from here on out, and act with logic over emotion.
A status update from Chaz is crucial right about now!
@Think4yourself1 I think we're already starting to see the SP make it's gradual descent as we close in on the 29th. Look for panic selling if no approval in 2 weeks.
It's almost time for hard decisions.
@iddrisw Fascinating insight and a reminder that this process has been playing out for over 5 years now.
Question about your statement re: BSI Netherlands. How does Nemaura /BSI get around Brexit if Nemaura is a UK company? I'm not clear on that.
@Whiskey Man, you got that right!
Dia bet...great post. BSI definately is the notifying body. Is there any way you can get back on that chat box and ask if there is any update or status on NMRD?
In previous posts I've expressed concerns about going into March Nemaura was in a race to receive CE approval before the March 29 Brexit date. If no approval in the next 30 days they never will be CE approved.
There now appears to be a strong chance Brexit will be delayed 2 months according to the below article. If true this is wonderful news for Nemaura. This is something we need to monitor.
https://www.telegraph.co.uk/politics/2019/02/24/exclusive-brexit-will-delayed-two-months-plans-considered-theresa/
What about those $150 million in pre-orders???? Any update on that?
Ok, I'm not trying to be negative, only objective.
Because this process has dragged out for so long, and being so close to the March 29 Brexit divorce date, it is highly possible that this stock will NEVER receive CE approval. Right?
And even if some process is put in place for UK-only certification, that would still take a long time as the process would have to start all over again. Correct?
Could this have anything to do with the goal post being pushed back again to June 30th?
From the last 10Q: " As the Company expects commercialization of the sugarBEAT device to occur in the first quarter ending June 30, 2019, approximately $99,000 and $70,000 of the deferred revenue..."
Any risk management strategies?
@Whiskey Previous discussions did not have a scenario where we would be approaching the March 29th Brexit date without CE approval.
I'm curious as to how the Brits view this.
Question about Brexit. Now that CE approval will be dragging into March, and the Brexit divorce date is March 29, is it possible that the EU agency that issues the CE will just not issue the approval since Britain will no longer be a member?
Could it be the EU has already set British approvals aside to give priority to members?
@Jreyes & Whiskey The only news I could find was proxy ballots and meeting info that came in my email. No sign of a promotion anywhere.
Great article, Dia bet. It sure looks like that whole CE system is messed up right now. It looks like EU patients will have to suffer YEARS of bureaucratic delays getting life saving products to the market. I agree it's hard to plug in an expected date.
At the same time Chaz says that both rounds of clinicals have been completed and all they are waiting for is the official sign off. My understanding from that video is that it's basically a done deal, right?
My only issue is the 9 months of misleading expected approval dates when in reality the clinicals were just completed in December. My position is down over $10,000 and it's starting to look like I'll be lucky to break even on CE approval announcement.
All that being said, keep an eye on your email. I believe Nemaura will again use Awesome to drum up attention before making the big announcement. Thanks for the info!