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Saturday, May 28, 2016 8:52:42 AM
http://www.xofigo-us.com/patient/index.php
Xofigo is a different isotope (Radium 223) used to treat prostate cancer. That product was sold to Bayer for $1B after being FDA approved in 2013
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352363.htm
If you look at References #5 & #6 in the Wikepedia page for Xofigo it will show Dr Fisher's involvement in the clinical trials and development. he was a pivotal member of the team to get that product approved as he worked closely with the FDA team to get it approved.
https://en.wikipedia.org/wiki/Radium-223
Dr Fisher met with the FDA in November with ADMD's top management to go over the test protocol to get Radiogel approved. He will also meet again with the FDA in the coming months to make sure everything is in order for the FDA submission.
Dr Fisher has previously stated that Xofigo was a much higher health risk product than Radiogel, and it was a difficult process to work through the risks with the FDA to get approved. He added that Radiogel is a safe product since Y-90 has been used in humans for years, and the Hydro gel is essentially made up of water, and that if presented correctly to the FDA, has a much easier pathway to approval than Xofigo.
Bottom line, ADMD has the right people in place to get Radiogel approved and who know the FDA panel members personally.
Once this is FDA approved ADMD is a billion dollar company easily. Sirtex has a $2B valuation and we have a superior product. FDA submission should come in Q4 this year
ADMD currently has a $25M valuation......do the math on a $1B valuation
oh and by the way, the chart signaled a breakout yesterday. the MACD and PPO crossed into positive territory yesterday for the first time in over a month.....it also closed above the 50 day avg......this next run should take us over .02 imo
Just like Trump, JK said "you're fired"!!!!!!
begging for $25k and denied
Recent RDGL News
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 09:30:31 PM
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