A friend of mine kindly sent the following. It may serve as a reminder that applying to the FDA and being granted anything can be many miles apart.
http://www.stockhouse.com/news/press-releases/2016/03/18/meet-the-biotech-company-about-to-turn-the-120-year-old-cancer-radiation
https://www.hotstocked.com/article/90558/fda-decline-destroys-advanced-medical-isotope-inc.html
The first one published on the 18th March 2016, sounds as if it is a hidden gem, with riches awaiting any smart investor.
The very next day, on 19th March, the FDA rejected the device, for further animal studies to prove efficacy.
From the first one;
The Wealthy Biotech Trader (or "WBT"), an investment newsletter focused on showing everyday investors new opportunities in rapidly growing, little-known, biotech, pharma and medical device stocks making news and subsequent market moves, would like to highlight a new stock pick, Advanced Medical Isotope (OTC: ADMD), which WBT believes has the ability to cause a massive paradigm shift in the cancer treatment space, and potentially capture a large segment of the burgeoning internal radiation therapy market. We look to follow this company as they expect to make another FDA submission later this year, which should catapult the stock if they receive the anticipated marketing clearance. We also contrast and compare a few other companies in the industry.
COMPANIES MENTIONED: Advanced Medical Isotope Corporation (OTC: ADMD); Sirtex Medical Limited (ASX: SRX); Accuray Incorporated (NASDAQ: ARAY); IsoRay, Inc. (NYSE: ISR); Actinium Pharmaceuticals, Inc. (NYSE: ATNM)
From the second one;
Back in December 2014 Advanced Medical Isotope Inc (OTCMKTS:ADMD, ADMD message board) filed a de novo submission with the Food and Drug Administration (FDA) for a marketing clearance for their Y-90 RadioGel Device. An answer was expected after a 120 days. .........
In a PR strangely titled “Advanced Medical Isotope Corporation Provides Commercialization and Strategic Plan Update” the company actually revealed that the FDA had declined the de novo request and that the RadioGelwill remain a class III device. This is the second time ADMD gets a negative response from the FDA after their product first failed to achieve market clearance back in February 2014.
Now the company has to complete preclinical animal trials in order to generate additional safety and effectiveness data before eventually submitting a new direct de novo filing.
......
To say that investors were disappointed by the news would be an understatement. Yesterday, the first session when investors had a chance to trade the stock after the FDA news was made public, ADMD got flattened to the ground. More than 752 million shares got dumped on the market. Just for comparison the 30-day average trade volume for the ticker is 27 million shares. As a result of the panic selling the stock lost 75% of its value closing at $0.0006 per share.
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