ROW ROW ROW HER BOAT
☞ Long-time readers may remember her last solo row, chronicled here exactly a year ago. Amazing.
Well, the real world is a lot messier than my fantasy world, where everything turns out right.
Guru writes: “I’m afraid this one looks dicier and dicier. They had a conference call Monday night to discuss the FDA’s refuse-to-file letter. The issue is that the company appears to have understated the safety concerns with the procedure – a lot. The FDA is asking for a thorough analysis of every patient who has been in a trial of the product – 186 in total for Phase I, II, III – to get a comprehensive understanding of the risk/benefit. In the presentation at ASCO in 2010, there was efficacy data on 44/44 treated patients, but safety on only 40/44 treated patients. Meanwhile, there was no safety data reported for 27 placebo patients who crossed over. I hadn’t really noticed this ‘missing’ safety data, but it certainly appears the FDA HAS noticed it. . . . A review of earlier trials shows that the procedure often could result in complications because of where the catheters were placed (especially if not done correctly). The big problem for the company is that the design of the trial did not allow them to show a survival benefit, leaving them only with a claim for a delay in progression, while at the same time, the FDA is clearly seeing that there are lots of potentially serious safety issues with the procedure. . . . In February, DCTH said they would file their response at the end of the 3Q. Now they are saying at the end of the 4Q. DCTH continues to insist they will get CE Mark clearance to market the product in Europe. I’m having a conference call with a consultant on Wednesday, but it doesn’t make intuitive sense that the Europeans would overlook these issues. . . . Finally, the FDA approval of Yervoy, a therapy that has shown improvement in survival in melanoma, from Bristol Myers, will impact the potential market size for DCTH. . . . At this point, I’m not really sure if DCTH will get an FDA approval. I’m afraid I was much too bullish on this one last year. Very sorry about that.”
☞ So what to do? The stock was actually up yesterday, in a falling market, so not everyone on that conference call saw the nuances Guru did. But who knows?
The risk is now greater than we thought – so I cut way back on my position yesterday. But if DCTH can find ways to satisfy the FDA, and perhaps improve training procedures for its technique, there could still be great potential. So I kept a little.
Fred Karger, the Republican presidential candidate I told you about Monday was interviewed on MSNBC yesterday morning and gave Mitt Romney a bit of a hard time. But that was nothing compared with what he wrote about Mike Huckabee:
Does the name Willie Horton ring a bell? Sure, the murderer of a 16-year-old boy who then Governor Michael Dukakis let out of prison on a weekend furlough. While furloughed, Horton left Massachusetts and went to Maryland where he brutally attacked an innocent young couple in their home. Rape and torture went on 12 hours until Cliff Barnes, who was stabbed 22 times, managed to escape and called police. Horton was captured, went back to prison and two more lives were forever changed.
I am very familiar with the case. I ran Committee for the Presidency on behalf of George HW Bush in 1988. We helped the victims of Willie Horton tell their stories.
Now, 23 years later, former Governor Mike Huckabee finds himself in a similar situation, only worse. While governor of Arkansas, 11 years ago, Huckabee commuted the 108-year prison sentence of Maurice Clemmons. Clemmons then went on a crime spree and ended up in Seattle, Washington, where on 19 November 2010, he casually walked into a coffee shop early one morning and shot and killed four police officers while they were eating breakfast. He fired at point blank range, killing all four instantly. . . .
☞ Obviously, Fred Karger is not going to win the Republican nomination. But he could sure shake up the debates.
Quote of the Day
Everything should be made as simple as possible, but not simpler.~Albert Einstein
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