SiNtx Technologies Inc (SINT)

[CL101]

Stealthways:

Yes, I agree! R/S = Bears always drool on this! They are so in love w/ stock that effects R/S = yummy short attack = kaching for them!

But...Why they are so afraid of AMDA R/S this time?...Brain washing the bulls to vote NO on R/S = Bear ultimate goal to delay the merger plan!

Usually, a stock effects R/S = Bears "cream" in their pants & happy! This time, AMDA R/S = Bears "crap" in their pants & panic! Wonder Why!!!???

Reverse psychology...all the REAL bulls should vote YES = OPPOSITE of what the bears want you to do!

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OhManIDied:

Can you simplify your question? Thanks!

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farmer6:

Answers to your question regarding the AMDA vs EX*L scenario:

1. A hidden GEM = 12 Mils nano cap (A) about to merge (horizontally) w/ a 25 Bil Fortune 500 Big Cap (Z) vs. an OTC crap (EX*L) does a "REVERSE MERGER" w/ a private company!

2. http://imgur.com/a/L4yEy

3. AMDA = The only company in this universe that has unique, MEDICAL GRADE Si3N4 for implantable medical devices in humans (Spine, Hip, Knee, Shoulder, Dental, Disc...etc) & Non-Medical Applications!

4. EX*L = Ones can find plenty of these on ebay or amazon (APPAREL:Chestee, Shirts, Compression Shorts, Leggings, Sports Bras)...LOL...

5. Only good thing about EX*L is this: http://imgur.com/a/hDRwx

*** Hope I answered your questions ***

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MBD:

WINK! Wie gehts? Have you called Sonny & Team to complain about their "stealthy" move to checkmate the bears yet? Tell them that you worry about your 500K-share position
...lmao...maybe they will disclose all the secrets instantly to all the shareholders...Tell them not to fool a 30-year veteran stock investor! Also, please tell them to hurry up
and shoot out the speculative merger news! We, the REAL bulls are counting on you pal! TIA!

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LexTrader:

WINK! How are you, bud?

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Santa:

WINK! How are you doing today? How is Ms. Claus doing lately?

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... who else did I miss to WINK! WINK! WINK! ...UH HUH...UH HUH...Peekaboo...I see you @@!

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http://www.amedica.com/news-media/events:

========================= PAST EVENTS ==============================

1. NSpine Main Conference (PAST - JUNE 12–JUNE 15, 2017)

*** I can't find the floor plan yet ***

+++++++++++++++++++++++++++++++++++++++++++++++++++++++

2. Ceramic Expo 2017 (PAST - APRIL 25–APRIL 28, 2017)

Exhibitors List :

http://www.ceramicindustry.com/ext/resources/Issues/2017/April/CI-Ceramics-Expo-Exhibitor-List.pdf

Floor Plan Image:

http://www.ceramicindustry.com/ext/resources/Issues/2017/April/CEX-Preview---0417-floor-map.pdf

*** ONLY AMEDCIA ATTENDED...ZIMMER WASN'T IN THE LIST = NOT CERAMIC BIOMATERIAL COMPANY ***

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

3. AANS Meeting (PAST - APRIL 22–APRIL 26, 2017)

Floor Plan Image:

http://imgur.com/a/6N2QD

Click Exhibitor List, then click the booth # next to Amedica or Zimmer:

http://www.aans.org/floorplans/AANS17/exfx.html#floorplan

*** Amedica & Zimmer were not nearby each other ***

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

4. AAOS 2017 (PAST - MARCH 14–MARCH 18, 2017)

Floor Plan Image:

http://imgur.com/a/1zeGc

Click Exhibitor List, then click the booth # next to Amedica or Zimmer:

http://s31.a2zinc.net/clients/AAOS/AAOS17/Public/eventmap.aspx?shmode=E&ID=1855&sortMenu=102000

*** Amedica & Zimmer were very far away from each other ***

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

==================== UPCOMING EVENTS ======================

1. CNS Meeting:

CNS 2017 Floor Plan Image (OCTOBER 9–OCTOBER 11, 2017)<<< I check Amedica website frequently...Last I saw was NOV not OCT...hmm:

http://imgur.com/a/lywBU

Click Exhibitor List, then click the booth # next to Amedica or Zimmer:

http://s15.a2zinc.net/clients/Corcoran/CNS2017/Public/EventMap.aspx

*** 10 STEPS AWAY & Zimmer has 4 booths this year (vs. only 1 booth in 2016) ***

*** Looks like these 3 smaller booths were purposely assigned to be closed to Amedica! ***


COMPARES TO 2016 Meeting:


CNS 2016 Floor Plan Image:

http://imgur.com/a/1eMWB

Click Exhibitor List, then click the booth # next to Amedica or Zimmer:

http://s15.a2zinc.net/clients/Corcoran/CNS2016/Public/EventMap.aspx

*** Very far away from each other & Zimmer only had 1 booth ***

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

2. NASS Meeting:

NASS 2017 Floor Plan Image (OCTOBER 25–OCTOBER 28, 2017)

http://imgur.com/a/09f2U

Click Exhibitor List, then click the booth # next to Amedica or Zimmer:

http://exhibit.nassannualmeeting.org/AM2017/Public/EventMap.aspx

*** The Guy next door & The Girl next door! Cuddling...like a newly wed couple! ***


COMPARES TO 2016 Meeting:


NASS 2016 Floor Image:

http://imgur.com/a/OLd78

Click Exhibitor List, then click the booth E next to Amedica or Zimmer:

http://exhibit.nassannualmeeting.org/AM2016/Public/EventMap.aspx

*** Both were very far away from each other ***

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@@@ 2 Events will be in OCT = 4Q ... esp. the (CNS Meeting will be on 2nd week of OCT..last time on Amedica website showed NOV..hmm..were hiding something?)! @@@

@@@ More evidences show that the speculative merger will be done before 4Q! @@@

@@@ Both upcoming events in 4Q ... A & Z are very close to each others ... Coincidences Again? hmm... @@@

@@@ Means the announcement should be anytime! Bears will get caught w/ their pants down & showing the little "zizi" @@@

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Brief history how FDA & ISO Cert. embarked in China:

FDA Quality Systems: If You Don’t Ask, They Won’t Tell

"In 2008, FDA opened its first overseas office in China. The agency now has offices in Beijing, Shanghai, and Guangdong.5
Its goal is to ensure the safety of products being imported into the United States from China.
By setting up offices in China, the agency hopes to work more closely with China’s State Food and Drug Administration (SFDA) to identify and prevent potential problems before products arrive at the U.S. border.
The plan is to work with Chinese manufacturers in order to educate and help them comply with U.S. requirements.
In February 2010, in a speech titled “FDA and the American Public: The Safety of Foods and Medical Products in the Global Age,” Margaret Hamburg, FDA commissioner, stated,
“Companies that sell contaminated products because of loose supply chain oversight need to face serious penalties. . .and cannot excuse themselves by blaming their suppliers, blaming FDA, or blaming anyone else.
Only when we have a sense of shared responsibility—and accountability —will we have a truly safe global supply chain.”6
It will most likely be easy to find plenty of manufacturers in China that are eager to work on a medical device project.
Additionally, it should not be too difficult to find suppliers that are ISO 13485 certified.
However, do not assume that this means that the manufacturer has a solid understanding of FDA quality system regulations.
There are plenty of ISO 13485–certified suppliers that would not come close to passing an FDA audit.
Even for those manufacturers that do have a strong grasp of FDA requirements, it is important to ensure their quality system aligns properly with the OEM’s.
This requires good planning and should be completed prior to starting any new projects."

http://www.mddionline.com/article/manufacturing-medical-devices-confidence-china

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https://twitter.com/amedicacorp?lang=en

Now let's talk about the ISO 13485:2016...

1. Version 2003 vs 2016:

http://www.sgsgroup.com.cn/en/Our-Company/News-and-Media-Center/News-and-Press-Releases/2016/03/New-ISO-13485-2016.aspx

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2. https://www.sec.gov/Archives/edgar/data/1269026/000149315217006356/0001493152-17-006356-index.htm

Click on the exhibit99-1 link:

https://www.sec.gov/Archives/edgar/data/1269026/000149315217006356/ex99-1.htm

*** Only talked about Japan PMDA...ones would wonder what about China CFDA = M.I.A...what is cooking in China? ***

"If China is medical device manufacturer, it must have ISO 13485 Certification.
If the products (medical devices) of China are to be sold in Japan, they must have an appointed MAH (Marketing authorisation Holder) in Japan,
which I believe is Japan ABC in this case and this MAH will register the product with PMDA-Japan, on behalf of China manufacturer."

https://elsmar.com/Forums/canada-medical-device-regulations/49208-iso-13485-china-manufacturing-facility.html

"Zimmer Biomet Holdings Announces Resolution of FDA Warning Letter Related to Its Zhejiang, China Manufacturing Facility"

http://www.prnewswire.com/news-releases/zimmer-biomet-holdings-announces-resolution-of-fda-warning-letter-related-to-its-zhejiang-china-manufacturing-facility-300472421.html

*** Really? another coincidence again? Really? ***

As a reminder: Why CFDA Clearance is important?

It will kick off this deal with Weigao Ortho Giant in China:

http://www.amedica.com/news-media/press-releases/detail/74/amedica-signs-exclusive-chinese-silicon-nitride

*** roughly 200K to 300K units on just 1 type of device: VALEO...addendums to contracts might follow later with other types of clearances in the future = Huge Future Revenue for Zimmer!) ***

*** There is no doubt Z will pay premimum for Si3N4 Tech ***

This is the list of products already cleared by FDA (There are others cleared in EU, Brazil, Australia,...etc...Japan & China coming soon):

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

*** in the "Applicant Name" field...just search Amedica Corp. ***

*** Of course the future killer of PEEK biomaterial = CSC + Valeo (Cleared in EU...The Bears BS about this clearance everyday!) will be taken care by Z after merger done...FDA won't give BIG Zimmer a hard time like they did w/ tiny Amedica! Size matter to FDA ***

"When your company sells medical devices in the U.S., it is mandatory that FDA enforce the law (Food, Drug and Cosmetic Act) using the QS Regulations to judge your manufacturing and design operations.
The ISO 13485 Standard is totally voluntary and, frankly, if your company doesn’t like the way that it is audited or the auditor that it chose, you can change auditors or, for that matter, change registrars rather seamlessly.
And yet another healthy dose of regulatory and business reality, my friends."

http://www.bonezonepub.com/1652-stop-treating-your-fda-inspection-like-an-iso-audit

"China FDA Proposes New Medical Device Clinical Trial Exemptions"
"The CFDA will accept comments from industry and other stakeholders on the draft lists through June 20, 2017.
The regulator last expanded its list of devices exempt from clinical trial requirements in September 2016"

https://www.emergogroup.com/blog/2017/05/china-fda-proposes-new-medical-device-clinical-trial-exemptions

*** Bascially, ISO Cert. is important & mainly applied in foreign countries like China, Japan, Australia, Brazil...etc ***

*** What is going on in China?...no ones know except Sonny & Team...We might have some big surprise out of nowhere (To make the bears crap in their pants!)...no one knows! ***

*** Could Weigao pulls some magical trick to convince CFDA for fast clearance (Clinical Trial Exemptions..US & EU Cleared & over 25K+ successful implants w/ 0 issue so far)... I won't be surprised if it is so...***

*** Is the last month updated version ISO 13485:2016 related to something in China or Japan as below ... ***

==================================================

3. Japan PMDA:

*** From Boston ***

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133950928

*** From Boston ***

"Specific links Chapter Two of Ordinance No. 169 and clauses of ISO 13485:2016 mentioned by the MHLW in the notice include:

Target manufacturers: Manufactures applying for new or partial-change Pre-Market Approvals or Pre-Market Certifications in Japan"

https://www.emergogroup.com/blog/2016/08/japanese-mhlw-takes-steps-toward-aligning-iso-134852016-its-own-qms-requirements

*** The recent update version of ISO 13485:2016 is possibly for prep. for PMDA clearance - Japan is a huge market due to high #s of elderly ***

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@@@ It looks like Sonny & his Team are waiting for something before they shoot out the merger news...but time is becoming very tight now if they want to close the merger before 4Q! @@@

All my opinions based on facts & links like always!

WINK @ " Popeyes ...how are you? Warum versteckst du dich...komm heraus und spiele mit mir?" WINK

WINK @ " 7948 M&M chocolate...I love M&M chocolate...yummy yummy yummy! "