Replies to post #61480 on CYduct Diagnostics Inc (CYDX)

[Verticalmojo]

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.

[BeauBeau]

what a Crock of BS... SNDY that is!!
What has Solos Endoscopy done over the last *8* years....??????

They have Leached their Lives off of SNDY Retail Shareholders and have Issued a Split Adjusted (Split Adjusted meaning the number of common shares that are Issued and Oustanding, without any of the "4" Reverse Splits that have been performed over the last "8" years) ...again.. and have Issued a Split Adjusted
4.5 Sextillion shares... I don't even think Extreme Dilution describes what they have done....

Here's 4.5 Sextillion in it's numeric form....

4,500,000,000,000,000,000,000

...in other words..
SNDY has issued a Billion shares.... 4.5 Trillion Times,.. !!! OMG!!!

FACT!!!!

That's alotta shares....!!!

[kurious]

I hope your post was sarcastic!