"AdvaMed's Medical Technology Learning Institute (MTLI) will be conducting workshops on the specific provisions of the new law next month in Washington D.C. (Dec. 8-9) and San Francisco (Dec. 11-12), to help manufacturers adapt to the new requirements.
"The workshops will provide an early opportunity for companies to hear directly from Japan regulatory officials about the details of the new requirements.
The world's second largest drug market just became easier and faster for VBLOC to enter:
WASHINGTON, D.C. – Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), today released the following statement in conjunction with the Nov. 25 implementation date for Japan's new Pharmaceutical and Medical Device Law (PMDL):
"AdvaMed applauds the entry into force of Japan's medical technology law, which regulates medical devices separately from drugs for the first time. Approved by the Japanese government one year ago, the PMDL creates a framework for regulation of medical devices and diagnostics that takes into account their unique characteristics and will help improve patient access to safe and effective medical innovations in Japan – the world's second largest market for medical technology products.
This very significant development will have a major, positive impact on medical technology manufacturers by streamlining regulatory requirements. For example, the new law expands the scope of products eligible for third-party certification, allows quality inspections to be conducted for product groupings as opposed to individual products, and simplifies the manufacturer accreditation process.
"The device-specific regulatory framework will dovetail with Japan's regulatory agency performance plan to facilitate timely product approvals in the country. Implemented in April, the updated performance plan has the ambitious goal of making Japan faster than the U.S. FDA in approving the most advanced category of medical devices.
If you look at the historical volume record, right here on Yahoo, you will see that OTC stocks tend to trade very thinly except for news events like the Ebola scare. Any positive news like additional grants or partnerships will double or triple GOVX with high volume. All I can advise is buy the dips. Zacks usually shyes away from OTC stocks, but they are very bullish on GOVX.
notamusedaa: do you still think the world is flat? Everything you said is completely wrong. Virtually 100% of companies issue a PR within 24 hours of an FDA decision-there is NOT a lot of work; the PRs have already been prepared in several formats.
Pharm: It was the sponsor who made the "hoping to have a decision for today's event" comment, NOT the company.
Ade: VBLOC does NOT have a monopoly on anything! In Thursday's presentation it was mentioned that there are a number of companies competing with ETRM for future approvals. The MONOPOLY is with the stingy payers.
Why don't you volunteer to try to get stingy payers to pay for your astronomical projections? No pay-very few procedures.
Use the low share price to buy more. Small and micro caps typically perform poorly vs. large caps near year end and then rebound in January. Any surprise grants or alliances can double or triple the stock over night.
Good news: Forbes article mentions GeoVax.
Bad news: GeoVax's chairman of the board, David A Dodd, is the CEO of AEZS, which just got a stinging rejection letter from the FDA.
I am long, but your figures are pure fantasy. VBLOC will be a niche procedure. Payers will be slow to reimburse. I can watch TV evengelists if I want to see the VBLOC miracles you posit.
Facebook CEO just donated $25M to the CDC. Other donors will follow and grant money to GOVX for Ebola and HIV/AIDS programs will surely follow.
Your volume figure is arbitrary. IBIO had volume beyond belief on Monday and is crashing today; meanwhile, GOVX is up 1 cent today. I'll take a controlled price runup vs. a flash in the pan.
Invest332007: More volume? GOVX on Monday had its highest volume day ever and has a modest share float.
You forgot to mention that GOVX also has a very promising HIV/AIDS vaccine program and even with today's jump, way below its 52-week high. IBIO may very well soar, but it is by no means a slam dunk.
Although plant technology is superior, the CDC will go with egg based vaccines in the near term, as a plant based vaccine is in the future.
I bought 12K today at .405 avg. I owned DVAX in 2008 when it soared 100% in 2 days. The Ebola publicity will only grow and if GOVX has an AIDS vaccine success the sky is the limit.
Unfortunately, any ETRM executive or board member who bought stock now would risk insider trading allegations if the FDA announced a positive decision in the near term. The time for ETRM mgmt. would have been to buy shares around Friedman's purchase. I lost big time on ENCY and CROX, but my friends who listened to me scored handsomely on these fallen angels.
The bond market and federal and many state and local offices are closed today and Wall Street is thinly staffed. Also, the FDA was unlikely to have issued a VBLOC decision on Friday as most of their staffers were probably taking a long weekend. Take today's action for what it is: HF trading desks and short hedge funds exploiting money making opportunities at ETRM's expense. Believe me, most of them are well hedged and will also handsomely participate in an ETRM run up.