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Close to market
It's about to explode !!
Pre-certification pilot program process
http://mhealthspot.com/2017/07/fdas-digital-health-precertification-pilot-program-open-applications/
Once a company is pre-certified, it's low risk products can go directly to market.
saMD means : Software as a Medical Device
FDA precertification program on Emergo website today and we know CYRCADIA is a client of EMERGO.
https://www.emergogroup.com/blog/2017/08/fda-pre-cert-pilot-medical-software-key-questions-and-eligibility-criteria
Yes ..and registration starting on August 1 and programm starting on September 1 are not the same thing . Could mean that precertification begins on September 1.
Pilot programm stars on September 1st
"When does the pilot program end? What is the last date for companies to apply to participate in the program?
There is no current deadline for applications— or a set conclusion date.
We intend to start the pilot by September 1, 2017, but we are limiting participation to nine. We encourage interested participants to apply as soon as possible."
https://www.fda.gov/MedicalDevices/DigitalHealth/ucm570617.htm
Rob Royea retweeted the news on Precertification on July 27 ... News could come faster than we think .
FDA announces pre-certification for #digitalhealth #startups by @chrissyfarr https://t.co/1DNMu3jdr2
— 🇺🇦 🇮🇱 Eugene Borukhovich (@HealthEugene) July 28, 2017
Registration for FDA precertication began august 1.
And Cyrcadia could get a precertification since it already had a device approved.
https://blogs.fda.gov/fdavoice/index.php/2017/07/fda-announces-new-steps-to-empower-consumers-and-advance-digital-healthcare/
Q2 says LLBO owns 47% of CYRCADIA
Good find
Less than 2 months before Breast Cancer Awareness Month. So i'd say less than 2 months before market
JMO
2 film festivals tomorrow for DETECTED. Great exposure !!
he sold half of his shares
Me neither. Launch in Asia soon could be anytime in the next 1 to 4 months.
If Cyrcadia is worth 3 Billions than LLBO is worth 1,35 billions . at 3,14 billion shares that's 0,43$ a share . Not counting the hype that could rocket it to 1$
And up to a good start this morning . 2 film festivals next friday afternoon.
2 film Festivals for DETECTED in 5 work days .
Market cap close to 1 billion
Launch in Asia will send this stock to a dime .
imo
And Rhode Island international film festival on the same date .
Well we know that Rob knows about this ..that's good .
And Rob retweeted it on Thursday
FDA announces pre-certification for #digitalhealth #startups by @chrissyfarr https://t.co/1DNMu3jdr2
— 🇺🇦 🇮🇱 Eugene Borukhovich (@HealthEugene) July 28, 2017
That's what i'm reading too, word for word
Wow super news this morning . thks change !!
Detected on the first day of Hollyshorts , same day as RIFF
http://www.hollyshorts.com/events17/
Very interesting.
LLBO is an investor. Of course it's not mentioned . People who run big funds know. That's what counts.
CYRCADIA mentionned on CISCO news site
https://newsroom.cisco.com/feature-content?type=webcontent&articleId=1870036
As we know Cyrcadia has hired AREA 23 for communications and they have a predermined plan. Winning the Lions was part of their plan.
translation :It works and is going to market ,globally.
"No healthcare company has ever won either of the awards for these specific categories, making Cyrcadia’s breakthrough dual awards another first for Cannes"
Cyrcadia won 2 Awards at Cannes
http://www.prweb.com/releases/2017/07/prweb14538444.htm
DETECTED at Rhode Island International Film Festival
On august 11
http://riiff.festivalgenius.com/2017/films/detected_sethkramer_RIIFF
same week as Hollyshorts
Good point ,anything is possible given the right offer.
Or someone just need rent money