More outdated info!
Wright Medical Group, Inc. Announces Receipt of FDA Not Approvable Letter for Augment® Bone Graft
Company to Host Conference Call at 3:30 p.m. Central Time Today
ARLINGTON, Tenn.--(BUSINESS WIRE)--Aug. 8, 2013-- Wright Medical Group, Inc. (NASDAQ: WMGI) today announced it received a not approvable letter from the Food & Drug Administration (FDA) in response to its Pre-Market Approval (PMA) application for Augment® Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.
In the letter, FDA states it is “concerned that the population enrolled was predominantly low risk and, therefore, may not have warranted the use of either autograft or Augment Bone Graft.” FDA went on to state it believes that “it will be necessary to perform a new clinical study that evaluates the use of Augment Bone Graft as a substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where the use of autograft would be clinically warranted.”
In summary, FDA concerns included “the patient population studied in the clinical study, the amount of graft material implanted, and the uncertainty as to whether any graft material would be needed or if the use of no graft material in a fusion procedure of the hindfoot and ankle in the population studied would have achieved similar results.” FDA provided a number of additional observations about the clinical study design and results.
“Needless to say, we are very disappointed by the FDA’s decision to issue a not approvable letter for our PMA application for Augment Bone Graft,” stated Robert Palmisano, president and chief executive officer of Wright. “This is not what we expected, as we believed that all of the FDA’s concerns as outlined in their previous not approvable letter from December 2011 had been fully and thoroughly addressed in the PMA amendment that BioMimetic submitted in June 2012. We are continuing to study the FDA’s position and expe
From Investors hub
WMGIZ is a Contingent Value Right
CVRs are given to shareholders as an additional benefit if a specified event occurs. A CVR is similar to an option. The payoff is contingent.
WMI acquired Biomimetic.The CVRs were provided to shareholders as a "sweetner".
The payoff for WMGIZ is two fold: (1) FDA approval of Augment® Bone Graft ($3.50) and (2) payment streams from sales revenue ($1.50 per share upon the achievement of $40 million in trailing twelve month sales for all products contributed by Biomimetic and $1.50 per share upon the achievement of $70 million in trailing twelve month sales for all products contributed by Biomimetic).
Sure we r here.
Good BUY? If you like to gamble! Your betting on the come and that's always high risk/high reward.
Hard to get any news on these 'rights"!
Well if you want a welfare state then vote for the democrats! Hand outs for any and all if they will just voted for them. And think of their integrity: Billy-Bob, Hillary and bo are the worst liars ever. And Billy-Bob is an abuser of young women and doesn't know what sex is!
And the more appropriate name should be: "CramCare". They could, they did, and now we have it! No input from anyone but Harry's and Nancy's boys and girls. In 2018, 80 percent of the nation were happy with their health care. Now 80 percent are unhappy. What a government we have.
Lets hope and pray and campaign for a republican sweep in 2014!