...the CEO, Steven Quay, invented an ultrasound contrast called "echogen" and started a publicly traded company called "Sonus Pharaceuticals"...well, in 2000, along came the headline, " Sonus shocks market by withdrawing EchoGen ultrasound contrast application"...HAW!...talk about your "deja vu"!!...
"The Bothell, WA, company said it was pulling EchoGen's new drug application (NDA) after the FDA told the firm that the filing needed a significant amount of work before it could be approved."
...and that was DESPITE: "Sonus reportedly was expecting to receive final regulatory approval for EchoGen this month."!!!...
...and it's AFTER the company goes around selling stock by telling everyone about the two BILLION dollar market for ultrasound contrast agents!...but NOW -- after filling his pockets with shareholder loot -- it's just too much "work" to get it approved!...
...you don't say:
"The company's regulatory nightmare began in 1997, when it participated in a lawsuit against the FDA over the agency's regulation of ultrasound contrast agents,..The following years saw Sonus stumble over one regulatory hurdle after another...In the meantime, Sonus suffered through shareholder lawsuits, the decline of its stock price, and the demise of business relationships with EchoGen's marketing partners."
...hoo-boy!...ATOS shareholders should find THAT reassuring!...
Sonus was trading around 30 dollars and had deals signed with major pharmaceutical companies. If it's drug application would have hit instead of missed it would have a billion dollar market cap. Problem is it failed it didn't get past clinical trials. It wasn't a failure of management, Quay had all his ducks lined up. That's why buffet never invests in biotechs, it's either a big win or a big loss. No one knows for sure until the clinical results come in. I bet Quay still losses sleep over that one.
While I was snooping around I just discovered why ATOS's system is far superior to the HALO. The HALO is only effective in drawing fluid around 50% of the time. The MASTC is close to 100% (97%). Big difference.
...uhhhhh, what part of "Sonus reportedly was expecting to receive final regulatory approval for EchoGen this month" did you not understand?...how about a little bit more:
"The Bothell, WA, company on April 19 received an approvable letter from the Food and Drug Administration for EchoGen, Sonus ultrasound contrast agent. The news most likely means that Sonus will win full clearance for the product in less than six months.
The FDA's letter covers the use of EchoGen in echocardiography applications, and states that Sonus must meet certain conditions before the agency will give the final nod of approval. The company was circumspect about the nature of the FDA's requests, stating only that it was pleased by the letter and believes that it has an effective strategy for addressing the agency's concerns and getting EchoGen cleared within a reasonable time frame."
...or how about:
"Sonus Pharmaceuticals' problems with the Food and Drug Administration appear to be getting complicated. The agency added insult to injury on March 26, when it issued a warning letter to Sonus regarding statements that the FDA said constitute promotion for the company's ultrasound contrast agent, EchoGen, which has not yet been approved.
Specifically, the FDA accused Sonus of disseminating promotional materials that contain statements or suggestions that are false or misleading."