TRADEMARK+FDA+ISO.13485+CE.MARK= MERGER/ACQUISITION 95% of the time.

Mammoview®

You just described a stock that is trading in the Pinks.

Now with all the expenses to achieve its goal of CE mark that really makes sense in why they needed to raise money.

Audit stage 2 is guaranteed by expert resources to pass the final audit, which will further support my opinions.

If the CEO of that company exercises his stock options (i.e. shares are created and issued to him to sell on the open market) his ownership stake will now be reduced, his share of the profits now drops. Larger stock dilutions will drop the value of his holdings even further. I'm sure that dilution will be minimal in the future.


Audit Day Table

http://www.whittingtonassociates.com/2012/09/audit-day-table/

I think a PR being released about a successful final audit would be a heavy blow and would prove a big win for SNDY shareholders and their confidence in SNDY's legitimacy.

We will see soon.....

#4, 1st list

SNDY IS MAKING PROGRESS Final Audit results will be released soon!

We do know that its guaranteed to be a successful final audit by expert resources!

"ER's approach to Management Systems consulting is very comprehensive, flexible, and affordable. Our consultants maintain a 100% success rate of attaining registration upon first attempt. ER also offers a compliance guarantee! Expert Resource guarantees that your documentation prepared by ER will pass the final audit, regardless of which registrar you choose to audit your management system. Beware of consultants who only guarantee based on the registrar they choose for you."

http://www.expertresource.net/ISO_Systems_index.html

Well there you have it, I'm assuming they know more than we do... thanks Don!

well I guess you missed it.

I've posted this before....


looks like 3 days

no. of employees-------days




The formal Certification Audit is conducted as
part of Phase 3. The audit is performed by an audit
team consisting of at least two members (exceptions can be made for small facilities). The duration
of the audits vary depending upon the size of the
company, complexity of the management system,
and breadth of manufacturing processes.
Upon completion, the audit team will generate a
detailed report outlining the results of the audit.

http://www.tuvamerica.com/services/qmservices/any_tms.pdf

A comparison of the FDA and EU Approval Processes and
their Impact on Patients and Industry


http://www.eucomed.org/uploads/Modules/Publications/2012_bcg_report_regulation_and_access_to_innovative_medical_technologies.pdf

Quote:
For large medical technology companies, FDA delays extend product lifecycles and create cash flow
fluctuations. The inability to prepare for product launches results in extended time before positive
cash flow can be achieved. Moreover, difficulties in predicting cash flow for development hinder
investment in new innovation. Future spending on R&D may also decrease due to costs of potential
delay. Despite these concerns, large companies are able to endure regulatory uncertainty much
better than smaller companies. In fact to some extent a high regulatory bar acts as a barrier to entry
to new innovators and may even reduce competition. Thus while a large company may have to forgo
near term revenues on a delayed PMA approval this can be offset by extended revenues on older
products that face limited competition.
While FDA delays may cause some difficulties for large firms, delays are almost certainly destroying
value for small firms. Often funded by venture capital firms, these companies receive funding based
on clinical and regulatory milestones in both the EU and the U.S. Regulatory and marketing success
in Europe is often required as a prerequisite for further support to enter the U.S. market. In fact,
venture capitalists we interviewed suggested that they would not be prepared to invest in a company
without confidence of an approval pathway and consequent revenues in Europe that would help
offset long and uncertain U.S. development and approval. However, with limited resources to fully
understand the EU regulatory environment and limited sales forces to tackle the numerous
countries within Europe, smaller companies are altogether disadvantaged. Smaller medical
technology companies, which often lack a portfolio of products to serve as alternative sources of cash
flow, are thereby more affected by the increase in U.S. approval times and the recent variability in
EU-U.S. approval delays. Faced with funding challenges, smaller firms may be forced to sell at low
valuations or to discontinue development efforts. With medical technology innovation heavily driven
by smaller companies, the ability for such firms to exist and continue to innovate in the long term is
certainly at risk.
In conclusion, while longer U.S. approvals may reduce returns for larger companies, smaller
companies encounter severe challenges. Funding problems due to extended EU-U.S. regulatory
delays may prevent life-saving innovations from ever reaching the market. Due to the likelihood of
undergoing a costly and lengthy regulatory process, companies may be less incentivized to innovate
and may pursue less risky products in the future. The resulting decrease in innovation could
jeopardize the competitive position of the U.S. in the medical technology sector.

The EU-U.S. device lag results in real impact to U.S. patients and U.S. companies. U.S. patients,
who experience over three-year delays in accessing new technologies, miss out on potential health
benefits that include reduced disability, improved quality of life, and greater patient choice. Small
device companies with limited resources suffer the most with approval delays, and many are unable
to withstand the costs of long regulatory delays. With the majority of innovation stemming from
small firms, the ability for the U.S. to maintain its competitive position and to produce technologies
to address the needs of U.S. patients is put at risk.
Our study does not prescribe EU regulatory processes for the U.S. or suggest that the EU process is
perfect. It does however suggest that the regulatory delays are detrimental to U.S. patients and
companies and that more rapid approval times in the EU offer significant health benefits to
European patients and to industry. Policy makers should be aware of the consequences of
increasing FDA delays and elongating the EU-U.S. device lag and of the potential negative impacts of
reforms to the EU process that would elongate European review times. If approval requirements for
complex medical devices are to be increased, they must be done so in a transparent and predictable
fashion that does not further jeopardize the efficiency of the regulatory process and reduce future
innovation.

Well said, CE mark will add VALUE to the company.

LOL Stage 2 Audit takes 1-1/2 to 5 days....

Just go for the bid, they want em.

Your missing a big part of this story, SNDY is a research and design company, their whole plan is exit via merger/acquisition. They do not put to much attention in selling their products but more into selling their research and design. Obtaining a CE mark is such a huge milestone because its then they become a target for larger company's that can absorb SNDY products into their catalog. SNDY knows its sales force cannot match those company's that dominate the medical device market and most company's like SNDY understand this. That is why 95% of them exit via m/a.

I guess we will see very soon.

GLTY

This is the road to ISO 13485

General_Conditions_and_Procedural_Guidelines_for_the_Registration_of_Quality_Management

Difference between PHASE 1 AND STAGE 1 FOR ISO 13485

A comparison of the FDA and EU Approval Processes and
their Impact on Patients and Industry


http://www.eucomed.org/uploads/Modules/Publications/2012_bcg_report_regulation_and_access_to_innovative_medical_technologies.pdf

What will larger companies such as those you see below be looking for?

I suggest all investors to read this

Download full copy at:
http://dspace.mit.edu/handle/1721.1/65522


Author: Kothari, Ashish (Ashish Shrikant)
Other Contributors: Harvard University--MIT Division of Health Sciences and Technology.
Advisor: Myron Spector and Carl Berke.
Department: Harvard University--MIT Division of Health Sciences and Technology.
Publisher: Massachusetts Institute of Technology
Date Issued: 2011
Abstract:
The aim of this thesis was to look at the impact of acquiring the CE marking approval on the outcome of early stage medical device companies, specifically its impact on strategic acquisition opportunities and on valuation. We gathered data on acquisitions of 237 companies over the past ten years, from April 01, 2002 to March 31, 2011. These data were gathered from various sources, and information on the date of acquisition, enterprise value, funds invested to date, date of incorporation, status and dates of CE and FDA approvals, patent status, type of regulatory clearances (PMA versus 510K), type of sales models (direct versus distributorship), capitalization status and last twelve month stock returns of the acquirer was acquired. These data were then analyzed using basic statistical methods and multivariate linear regression analyses to determine the significance of the CE marking on the outcomes of these companies. Our results support the claim that the CE mark does significantly improve outcomes for early stage medical device companies, in terms of time to strategic acquisition, which is by far the commonest exit route for these companies. On the other hand, we did not find any statistically significant impact of acquisition of the CE mark on the valuation or valuation multiples of these companies. These results have potential implications for management of these early stage medical device companies in making strategic decisions and for investors who are concerned about the exit opportunities and valuations, especially as it relates to funds invested. There could also be some policy implications in terms of the effort, duration and cost of getting a CE approval versus that of an FDA approval, which is especially important given the current growing concern about increasingly stringent regulation, rising costs and increasing delays in FDA approvals for medical devices.
Description:
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2011.Cataloged from PDF version of thesis.Includes bibliographical references (p. 85-87).
Keywords: Harvard University--MIT Division of Health Sciences and Technology.

There you have it folks

So I'm sure you had a chance to read my questions, can you answer them?

Can you show where you are getting these numbers and dates of dilution?

Grotesque? They don't even exist! lol

Well since march of 2012 you have been on this board, we have not seen any trips or a R/s but we are supposed to believe you? Also, during that time SNDY has made 4 or more runs....

Thats not even getting the ISO 13485 or CE mark. Thats just on the news of its progress.

Thats good and I am sure your a billionaire by now old sport. Thanks for reminding us when the PPS ran to .0085 on just stage 1 audit announcement. It started at this level, so that means they must of RAN THE PRICE UP for the dilution right? How does a stock being diluted go up?

How long you been waiting? about a year now?

I hope you get those shares your waiting for. .0009 right?

Speaking of successful Audit results...

check this out old sport...

95% exit via Merger Acquisition After FDA & CE Mark

Good luck with the short squeeze old sport

I am expecting folks who are trusting your opinion will be jumping on board once news hits, at this level or higher than .0033.

Well your you forgot to mention that the company will be primed for M/A when the CE mark is awarded, which makes sense why they had to raise the AS.

Also...

Those shares really don't exist..

Think of the number of authorized shares as the current maximum number of shares allowed to exist, but they don't quite exist yet.

Authorized shares do not exist until they are issued. "Authorized shares" is actually a kind of misleading term.

Authorized share capital is often not fully used by management in order to leave room for future issuance of additional stock in case the company needs to raise capital quickly. Another reason to keep shares in the company treasury is to retain a controlling interest in the company.

Also when acquired, their shares would be absorbed and converted to the parent/new company's shares.

SNDY continues to take the steps in reaching a level where they would be recognized by larger firms.

Medical device industry is full of research and design microcap companies, which all are trying to reach the same goal.

Many of those companies fail, not being able to raise enough funds to reach the required milestones. This is why SNDY comes as a surprise, because even though many similar companies are FDA approved, reaching CE mark seems to be more difficult since many are rejected or have difficulty with the process.

SNDY realized this, and they knew that reaching ISO 13485 would be too difficult and time consuming if they tried to pursue it on their own.

This is when they hired expert resources. A expert at ISO 13485 and preparing for Audits. So good that they guarantee a successful final Audit. Thats a pretty high standard and is one that is yet to be argued since its history proves its true.

Now this is the part that confirmed that SNDY was the real deal, and built my confidence.

They scheduled a stage 1 Audit, and passed!

Now SNDY history about dilution and R/S is expected. WHY? It trades in the pink sheets. This is where companies focused on R&D or have an idea but don't meet the requirements to enter a real exchange. Revenue is not supposed to be great at this level. The company is here to raise funds for things like Expert resources, trademarks, FDA fees, R&D, etc....

ITS WHAT THE COMPANY IS DOING WITH ITS RAISED CAPITAL THAT MAKES THE DIFFERENCE.

Its a good time to be in SNDY and expect things to unfold nicely.

watch for the .0033 breakout...

Look for .0033 breakout, buyers looking to add at this breakout as well as shorts looking to cover their position will push the PPS even higher.

PR of audit stage 2 completion or CE mark could be the momentum starter for SNDY.

Being a shareholder, I've always felt good about my investment and have nothing but good things to say about Solos Endoscopy. Big press release this week IMO.

95% exit via m/a are pretty good odds, but 100% success rate guaranteed is slightly better old sport!

Expecting audit 2 results this week.

Party at my place!

They raise capital, like every stinky pinky. Thats why they trade at this level. It really shouldn't be surprising to see that behavior, so the humor I find is your worried about a apple in the fruit salad, if its a steak you want you would would find those in the NASDAQ or NYSE.. everybody knows the risk down here.

SNDY is a pink. But a pink who is making moves!

Those shares really don't exist..

Think of the number of authorized shares as the current maximum number of shares allowed to exist, but they don't quite exist yet.

Authorized shares do not exist until they are issued. "Authorized shares" is actually a kind of misleading term.

Authorized share capital is often not fully used by management in order to leave room for future issuance of additional stock in case the company needs to raise capital quickly. Another reason to keep shares in the company treasury is to retain a controlling interest in the company.

Anything can happen like early exit via M/A or the PPS reaching pennyland, I agree. But there's an old saying... Stinkie pinkie only when you drinkie. Not sure what that means but you get the picture old sport.