Great find, The positive news just keeps rolling in. Amazing how we are always mentioned
as top in AI medical devices
I think huge buyout with big-name player soon!

I believe this company is understaffed that is why we don't see many updates. The prototype should be out soon, then the launch date in Asia. In my opinion, they will proceed with fulfilling all requirements, testing Etc. for FDA approval for USA distribution.

. The investors who wait this out several months will be rewarded. Yes, it is a gamble like all penny stocks. To stay invested here you must believe in the product, the huge potential profits and of course the saving of many women worldwide! Let's face it, what sub-penny STOCK is up there with all the big names in the Artifical intelligence market!

Yes, I used https://yandex.com/ and they let me view the website. So yes probably google

iflytek also mentioned here, AI in China is getting a lot of attention

https://asiancorrespondent.com/2018/06/china-to-employ-artificial-intelligence-to-help-its-aging-population/

This is exciting they will probably update over the weekend for next weeks launch. Just in time for October Breast cancer awareness month
Good luck to all Longs its been a long ride!

Another excellent article, Great Research intexp. It is crazy how we are all invested in this company
that can benefit woman all over the world. We are the favorite horse at the gate GO LLBO

Yes, it is very frustrating!! What gives me a hope is all the current positive news. Cyracadia Asia has been leading the way with top Doctors, investors, AI Technology companies and Cisco to name a few. And not to mention all the potential patients in Asia that cannot afford, nor have access to mammograms or even to see a doctor. This is the first time in many years that I see the light. I for one will hold on it may be the best investment I ever owned.

Most of the latest news suggested that the launch will be in the third quarter 2018
To make myself feel better I looked up the definition

A quarter refers to one-fourth of a year and is typically expressed as "Q." The standard four quarters that make up the year are: January, February and March (Q1); April, May and June (Q2); July, August and September (Q3); and October, November and December (Q4).

So Q3 could be this month

This is great for the helping with breast cancer detection, we need all the help we can get. The itbra, on the other hand, will be more affordable and available to all woman around the world that don't have access to this technology.

Yes. We just need news of FDA approval here in US or news of the Launch and there will be no turning back. Cyracadia will be a pioneer in AI health tech. Hope it will be like buying Microsoft in the 80's

well said! LLBO is one of the most exciting stocks I have ever owned

of course, people that have been on this board for that many years are frustrated. All our stars are lined up. With the launch of itbra this stock will be soaring higher than ever and I would hate to sell now and miss this great opportunity

There are so many big players involved with big investments I don't think you can time this, it will
happen. You have been a strong voice here and kept me here for many years. Of course, you must make your own financial decisions but the finish line is so close.

Is anybody else having trouble with Lifeline's website
It is coming up with suspicious malware

At least most of us agree this stock will go way north GO LLBO!!

Just thought i would repost "Domains" DD He was very helpful

Domains Tuesday, 04/25/17 06:56:11 AM
Re: None 0
Post # of 26211
DD: On the FDA approval process for the iTbra

For those who do not want to waste time in reading the official documentation, here are my conclusions (IMO):

- Cyrcadia "should" publish the change of status "within 30 days of a change". But they are not obliged to do it.
- Cyrcadia must submit summary results no later than 12 months after the date of final data collection for the prespecified primary outcome measure. So, in this case it is compulsory and clinical trials results could be public at any time before or after the documentary release.
- It may be that Cyrcadia has already made the application for FDA approval and that it has already obtained the approval. But it is also possible that this clinical trial is considered an improvement of the previous product already approved, and that does not require the approval of the FDA to initiate the commercialization.
- From my point of view the clinical trials are finished and are a success. Cyrcadia will be using this documentary/film to start their communication campaign all over the world.
- Not having the clinical trials finished by the time the film is released would be crazy for CISCO. Remember that is CISCO who has paid for this film. And that the film was intended to show the entire process from conception to approval by the FDA according to statements from all parties involved.


DD REFFERENCES


When Cyrcadia will publish the results?
Just as a reminder of what they stated when they announced the clicnical trial expansion to The Ohio State University, in Columbus, Ohio (press release APRIL 05, 2016).
http://www.prweb.com/releases/2016/04/prweb13312355.htm

Quote:
As we evaluate and potentially add new sites to the study, we will post final results of the study on clinicaltrials.gov. once we have reached clearance by the FDA or final trial enrollment.”

Quote:
Per Federal FDAAA 801 guidelines, Cyrcadia will release information on trial location additions, as well as clinical trial data only at time of trial completion or FDA clearance for disclosure.


To clarify FDAAA 801 Requirements (official infrmation):
https://www.clinicaltrials.gov/ct2/manage-recs/fdaaa


Required Registration Updates (official information)
https://www.clinicaltrials.gov/ct2/manage-recs/how-edit

Quote:
Responsible Parties should update their records within 30 days of a change to any of the following:

Recruitment Status and Overall Recruitment Status data elements on ClinicalTrials.gov
Completion Date (See Primary Completion Date data element on ClinicalTrials.gov)
Other changes or updates to the record, such as protocol amendments, must be made at least every 12 months. It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.



Clinical Trial Protocol: Completion Date (official information)
https://prsinfo.clinicaltrials.gov/definitions.html#PrimaryCompletionDate

Quote:
Primary Completion Date *
Definition: The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.

Once the clinical study has reached the primary completion date, the responsible party must update the Primary Completion Date to reflect the actual primary completion date.

Study Completion Date *§
Definition: The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.

Once the clinical study has reached the study completion date, the Responsible Party must update the Study Completion Date to reflect the actual study completion date.


About the need and timing to publish completion results:
https://www.clinicaltrials.gov/ct2/manage-recs/how-edit

Quote:
For certain clinical trials subject to Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), the Responsible Party must submit summary results no later than 12 months after the date of final data collection for the prespecified primary outcome measure (see Primary Completion Date data element on ClinicalTrials.gov). See How to Submit Your Results and FDAAA 801 Requirements for more information.



Current clinical trial status (official information):
https://clinicaltrials.gov/ct2/show/NCT02511301

Estimated Enrollment: 173
Study Start Date: June 2015
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)


About the type of the study conducted with the iTbra (blog 2015/04/18):
http://hiddenremote.com/2015/04/18/detected-is-a-film-that-could-change-the-world/

Quote:
Rob Royea, CEO of Circadian Health: Our clinical trials will be conducted in conjunction with the FDA’s Early Feasibility Investigational Device Exemption program


About FDA’s Early Feasibility Investigational Device Exemption program (official information):
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103


Approval protocol of Nonsignificant Risk Devices (official information):

- IDE Approval Process (official information):
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm

Quote:
A nonsignificant risk device study requires only IRB approval prior to initiation of a clinical study. Sponsors of studies involving nonsignificant risk devices are not required to submit an IDE application to the FDA for approval.


- Information Sheet Guidance For IRBs, Clinical Investigators, and
Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies (official information): https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126418.pdf

Quote:
These abbreviated requirements address labeling, IRB approval, informed consent, monitoring, records, reports, and prohibition against promotion. However, there is no need to make progress reports or final reports to FDA.


- Frequently Asked Questions About Medical Devices (official information):
https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127067.pdf

Quote:
A premarket notification, or 510(k), is submitted to FDA before a manufacturer proposes to market a medical device. If FDA agrees the new device is substantially equivalent to a legally marketed device for which premarket approval is not required, the manufacturer may market it immediately. FDA does not require clinical data in most 510(k)s.


Quote:
A premarket approval (PMA) application is the most stringent type of device marketing application for medical devices. FDA approves a PMA if it determines that the application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).


Quote:
Examples of exempt studies are consumer preference testing, testing of a device modification, or testing of two or more devices in commercial distribution if the testing does not collect safety or effectiveness data, or put subjects at risk.4 Studies of an already cleared medical device



DETECTED at the IFFBoston 2017 Shorts
http://prod1.agileticketing.net/websales/pages/info.aspx?evtinfo=118600~a237b910-f867-48f1-bae1-19794b59b1f0&;

Quote:
Cancer survivor Melanie Griffith tells the story of a device intended to save the lives of millions of women: a bra that detects breast cancer.


Trailer:

I think Jim Holmes maybe directing more cash investment into Cyrcadia , but you are right if either one hits he and his family is set for life

Of Course anything could happen, but Jim Holmes is still one of the largest
shareholders of LLBO and has been determined to see this through

For the newbies check out this movie funded by Cisco
http://detectedmovie.com/

Looks like we are not going to buy at this price much longer!!! GO LLBO

Hi Mead If you could add me to the long and strong list. Thanks again for your help with this board

Look PB This is all the current news from Lifeline website
All current and all positive!

Lifeline
News
06.26.18 Reno, NV Cyrcadia Health Announces New Medical Advisor, Kevin Buckman, M.D.
3 weeks 5 days ago
Dr. Buckman has over 35 years of Emergency Medicine Experience and is currently a Physician with Team Health in Lodi, CA. He has served as Medical Director or Associate Medical Director in hospitals and institutions for over 20 years and has over 40 years of clinical experience. He has served as Medical Director in the […]
admin
Reno, NV June 12, 2018, Cyrcadia, Inc. New Member of Board of Directors
1 month 1 week ago
Cyrcadia, Inc. is pleased to announce the addition of Ed Wertzberger to the Board of Directors as we continue to focus on implementation of our aggressive growth strategy and Go-To-Market plan. Jim Holmes, Chairman of the Board, says, “We are pleased to have an executive join our Board who possesses extensive leadership and global experience. […]
admin
Reno, NV May 29, 2018, Cyrcadia Health “B” Warrant Acceleration Option
1 month 3 weeks ago
Based on 2018 Go-To-Market plans, investment infusion is paramount in keeping on track and maintaining our accelerated pace. Our stakeholders have been essential in supporting our march to bring the most advanced Breast Health product to market. For those stakeholders holding “B” warrants, the warrants will expire December 31, 2018, meaning conversion to shares in […]
admin
Reno, NV May 21, 2018, Key Partnerships for Cyrcadia Health
2 months ago
Three key partner relationships are in place to bring “Best of Breed” subject matter experts into the Cyrcadia Health, Go-To-Market sales launch plan: Consumer Marketing: Dupuis Marketing, Chicago: branding, packaging, social media advertising, and user experience design. “We develop and create business opportunities that establish new meaning for people–digging for deeper truths beyond commonly leveraged […]
admin
May 14, 2018, Reno, NV. Artificial Intelligence Advancements
2 months 1 week ago
New discoveries have been achieved with our artificial intelligence (AI) algorithms. Recalling the foundational basis for the Cyrcadia Health intellectual property and patent filings is five algorithms that analyze tissue temperature and circadian body rhythm disruptions over a time period (dynamic) to identify tissue abnormalities. “Recently, our AI software scientists have made new discoveries that […]
admin
May 4, 2018, Reno, NV. Expanded Go-To-Market Team
2 months 2 weeks ago
Cyrcadia, Inc. is pleased to announce the addition of Marly Heidkamp, Chief Operating Officer, R.N., MSEd to the executive team to focus on execution of the Go-to- Market plan. Jim Holmes, CFO, say, “We are pleased to have an operations executive join our team who possesses medical product management experience as well. We are confident […]
admin
April 30, 2018, Reno, NV. Clinical Trial Resumption Update
2 months 3 weeks ago
As Cyrcadia prepares to move to clinical markets, Matt Benardis, CEO; Jim Holmes, CFO; along with our Clinical Research associate (CRA) met with clinical trial investigators and administration at El Camino Hospital, in San Mateo, CA, to discuss previous participant follow-up and trial resumption with our modified clinical product and associated study protocol. Do note […]
admin
Cyrcadia, Inc. – 2017 Year End and 2018 Look Forward Newsletter
5 months ago
February 27, 2018 Cyrcadia, Inc. (“CI”) extends its thanks and appreciation in your interest and support of our endeavors. We are taking this opportunity to provide an update, as well as apprise you of upcoming expectations. License and Cooperation Agreement with Cyrcadia Asia (“CA”) – Status Earlier in 2017 CI entered into an Agreement with […]
admin
Cyrcadia, Inc. Wins Prestigious Cannes Lions Awards
11 months 4 weeks ago
Cyrcadia, Inc. (CI) announced it has won two prestigious awards at the Cannes Lions International Festival of Creativity, a global event for the creative communications, marketing and advertising world. Held in Cannes, France and attended by over 10,000 delegates, Lion awards are considered the most coveted in the industry. The first award was a Bronze […]
admin

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Thank you for stepping up to the plate. We all have a great investment in a truly amazing company
and for all woman all over the world. GO LLBO

Great posts keep up the good work! The big problem I see is there is no obvious connection between
Lifeline and Crycadia. We are all invested in Lifeline and they are very careful about news releases. If any body remembers the chill several years back
On a Good note Crycadia is really pumping out more news and related articles in the past Six months then ever before. We are getting close

Awesome
Go LLBO!!!

Just a theory here guys. PenBlanc (PB) disappears and PharmaBro appears (PB)
Just saying

As per "domains" His expected news is starting to come true!
Domains Thursday, 09/28/17 01:51:45 PM
Re: None 0
Post # of 25298
Expected news in the next 12 months (order may vary):

- The Detected film produced by CISCO is made public
- Activation of the web http://cyrcadia.asia
- Completion of clinical trials and final data released.
- FDA approval (Class I)
- Cyrcadia Inc receives new financing above $2/share
- Start of the iTbra production
- Cyrcadia and Lifeline Biotechnologies update their websites
- Cyrcadia and Lifeline Biotechnologies begin to communicate again in social networks
- Publication of articles from media all over the world (top media also)
- Agreements with hospitals in Asia and the US
- Agreements with insurance companies in the US and other countries
- Cyrcadia and CISCO start their communication campaign to the media
- Public launch of the iTbra and the mobile app
- Approval of the iTbra by the regulatory authorities of Hong Kong (China)
- iTbra Launches in Hospitals in Hong Kong and other countries in Asia
- CISCO reports on how the iTbra uses its infrastructure
- Real-life case stories about how the iTbra starts saving lives
- First sales figures in Asia
- iTbra Launches in US Hospitals
- First US sales figures
- Cyrcadia Data (Ireland) reports on its activities
- Launch of iTbra Over The Counter in the US
- First sales figures Over The Counter in the US
- Approval of iTbra by the regulatory authorities of Europe
- iTbra launches in Europe
- First sales figures in Europe
- ...

All these milestones are likely to generate a press release and a price spike.

Who in their right mind is going to sell now after years of development and waiting? NOBODY!

When the news starts arriving, LLBO will become trending topic for OTC investors and the expectations can make the price increase exponentially between $0.01 and $0.10

Wow Penblanc can sell now!

Detected movie watch for free

Joie Healy
?

@JoieHealy
20h20 hours ago
More
Check it out @detectedmovie is now available for you to watch - free! http://a.co/9tBEEXP Loved working on this with our @Cisco team. Great job @IBFilms #DetectedMovie

I think this statement clears up the myth that they are not working with the FDA
There so much positive news we should not be cherry picking and looking for negative
Good luck to all longs this is our year
Regulatory Clearance, Trials Recap

CI’s current US trial success has allowed us to utilize a Non-Filing Justification (NFJ) with the FDA, under our current FDA 510(k) Class II clearance, enabling CI to go to market. Additionally, CI and CA have contracted with two regulatory advisor contractors to drive to a Class I designation (Over the Counter and direct to consumer markets) allowing for entry into market without the scrutiny of a class II device (Clinical, prescribed by physician market), as the iTBra™ stands now. The intent is launch into both the consumer and Over the Counter (OTC) markets almost simultaneously with the clinical markets. Thus far, indications are favorable for this approach and we will be meeting directly with the FDA in the months to come, declaring our intent. We will report again on the meeting outcomes once definitive. Moreover, CI will pursue a Modified 510(k) through the FDA enabling the rapid expansion of the clinical markets. This does not preclude us from going to market with our existing 510(k), Class II clearance (see the NFJ position above), but will certainly enhance our visibility and buy-in from the medical/clinical community.

Awesome I think this line addresses the Mexican kid

Competitive Analysis

No competitive technologies have materialized that would threaten our business plan. We are confident our intellectual property filings are a significant barrier to market entry and our usage of artificial intelligence software is market leading technology. In addition, our contract for manufacturing in China ensures a high volume competitive product cost.

Did anybody see this news on crycadia website, looks promising

Cyrcadia, Inc. – 2017 Year End and 2018 Look Forward Newsletter
by admin | Feb 21, 2018 | News
February 27, 2018 Cyrcadia, Inc. (“CI”) extends its thanks and appreciation in your interest and support of our endeavors. We are taking this opportunity to provide an update, as well as apprise you of upcoming expectations. License and Cooperation Agreement with Cyrcadia Asia (“CA”) – Status Earlier in 2017 CI entered into an Agreement with CA, whereby CA assumed the responsibility and funding of the design, development and delivery of a scalable, commercializable iTBra™ system including upgraded hardware and the full suite of application software as well as automation of our proprietary Artificial Intelligence Analytics. The estimated cost of development with Jabil and Mobile Now is approximately $1.2 to $1.5 million US. As such, the agreement calls for CA to provide timely reporting and status of product development including timelines, milestones and dates of completion and delivery of product (market readiness, product volume availability and delivery terms and schedules). Many strides have been made in the evolution of the relationship as CA has established its operations, initial staffing and funding. Both CI and CA are in a mode of cooperation, as called for by the Agreement and, presently, both entities are to hold routine meetings where comprehensive updating and reporting will be delivered to CI, enabling implementation of our business, operations and marketing plans. We will be reporting the outcomes of that meeting to move forward on our ability to commercialize the iTBra™ system this year. Given the above, we would like to update on the internal operations that will allow for CI to “hit the ground running” upon product delivery. Status of Product Development and Manufacturing Under CA’s...

Anyway Sorry for my first time post must have hit submit way too fast
I have been here many years as well, But if you can read between the lines
this will be our year. Asia and US liftoff The Cyrcadia team is still out
pitching the product
https://www.healthtecho2o.com

Anyway Sorry for my first time post must have hit submit way too fast
I have been here many years as well, But if you can read between the lines
this will be our year. Asia and US liftoff The Cyrcadia team is still out
pitching the product
https://www.healthtecho2o.com

Just extend some patience We are all here for the success of this company
https://www.healthtecho2o.com/speakers-1