Are You a Pregnant Conservative Jewish Small Businesswoman? January 23, 2012March 26, 2017 OWN OR WORK FOR A SMALL BUSINESS? A friend has launched BestVendor, to help small businesses decide what software to purchase (and, one day, what everything-else to purchase). ‘I use Amazon to figure out what book to read,’ he says, ‘I use Yelp to figure out what restaurants to go to, but there’s no go-to place if I need new project management software. And yet peer recommendations are the number-one driver of purchasing decisions.’ So if you’re willing to share your opinions of the software you own, you’ll have access to the opinions/ratings of thousands of others. Free. JEWISH? If you doubt that the Obama Administration has been and will remain a great friend of Israel – a charge Republican opponents have leveled – watch this 7-minute video, and/or forward it to friends you think may have bought the Republican line. CONSERVATIVE? Rick: ‘The Andrew Sullivan column you posted Friday summed up my thoughts really well, my being a conservative frustrated with the GOP and an Obama supporter in 2008 (as well as 2012). Many of my conservative friends can’t figure me out. I forwarded Sullivan to one such thinking friend and received the following response today: ‘Congratulations, you’re starting to make me a believer.’ I just wanted to let you know, ‘got another one!’ LOL!’ Mark Laurel: ‘Mr. Sullivan repeats a common error when he states that hospitals must ‘accept all emergency room cases requiring treatment…’ By federal law, hospitals only need to treat emergency conditions, and then only until the patient is stabilized. Show up at an ER for prenatal care, and it’s not likely you will get it. Getting basic health care through the Emergency Room is inefficient, as Mr. Sullivan writes, but not guaranteed.’ CBRX One savvy reader: ‘The FDA voted 13-4 ‘no’ on efficacy. These guys were supposed to be statistically significant at a p of .01, as they are attempting to get approval on a single trial, as the FDA did not consider the Fonseca trial as evidence. I can’t believe Guru fooled himself like this. If this company had cash to fund a second trial, this would ultimately get approved. But they don’t.’ Guru: ‘First time I’ve ever seen a panel vote down data that met its prespecified statistical plan. Introduces an entirely new level of risk in my assessments going forward. The FDA guideline for p < 0.01 is a guideline, not a requirement, and in fact, DNDN was approved under the ‘single trial guideline’ (as can be seen on the FDA’s website) with a p of 0.034. I spoke to a Harvard doctor and an ex-FDA reviewer before this meeting and both expected the vote would be positive. Stock should open near 0.50/share, but then bounce. The product is actually on the market, doctors are using it (Duke, Harvard, UCLA, etc.) sales are accruing. CBRX has 0.25/share in cash and is profitable. So it could rally back to 1.00/share or so. . . . What is also interesting–and disturbing–is that CBRX represents a continuing trend in which products that met the standard scientific criteria for success are being rejected by panels and the FDA. From 1998 to 2008, I made good money betting against stocks whose products truly had not met their primary endpoints, but were advertised as being effective anyway. Now, I must think through studies that HAVE met their pre-specified endpoints, have prior studies that are supportive, and have reasonable mechanisms of action and STILL get rejected because – it seems – ‘the data just aren’t good enough.’ New standard for ‘good enough.” Savvy reader (again): ‘Guru’s right about that last part for sure. I watched the webcast today thinking the FDA is just absolutely broken. The four people on the committee who voted for approval were people I would want making these sorts of decisions. A couple of the people on the panel who voted against seemed embarrassingly stupid. One of them made a remark about how, given how well-powered the trials were, the drug must not work, and he bet that if they repeated the trial again, it would show ‘the same result.’ Of course, the same result would be a big reduction in preterm birth with a p-value of .02, but somehow he thought that meant the drug didn’t work. The drug almost certainly works; it just didn’t stand a chance against these guys.’ Guru again: ‘Given the extreme safety of the drug, the seriousness of the condition, and the already widespread use of the product AND given the Fonseca study which used a different version of the same product, it seemed to me an easy vote for ‘yes’ for a clinician and that the clinicians would win the day. That analysis turned out to be wrong. I expect the company will give a conference call on Monday. There is currently about 0.28/share in cash. I expect the stock will open in the 0.50-0.60 range (2 x cash) and trade up, perhaps to near 1.00. The question is whether WPI will decide to undertake another study or whether they will continue to market Crinone for its approved uses and allow it to be used off label. The FDA deadline for a decision is Feb 26. The FDA did approve Xarelto despite a negative panel vote. Likewise, the FDA approved OSI Pharmaceutical’s drug for lung cancer despite a negative panel vote. Of course, the FDA team was quite negative on Friday, so it is not obvious the FDA will approve CBRX on Feb 26. Still, CBRX’s product is already on the market, it is exceptionally safe, there is a move at the American College of Obstetrics and Gynecology to make use of vaginal progesterone the standard of care for women with first time pregnancy and short cervix, and the FDA could potentially satisfy the need for additional confirmatory data by asking the companies for an additional post-marketing study, rather than a pre-market study. I spoke to people at the Cleveland Clinic and at Harvard’s Brigham and Women’s Hospital and they said it would unethical for them to run placebo-controlled trials for women with short cervix. Professors at Duke and UCLA testifying for CBRX (without payment) on Friday said the same thing. The NIH ran the most recent CBRX trial and the Division head, Roberto Romero, likewise indicated at the meeting the NIH would not be able to justify a placebo controlled trial either. Up to 10% of pregnant women have a short cervix. That’s 400,000 births a year likely to be pre-term. The cost of treating a pre-term infant can easily exceed $50,000. If we could reduce this number by any meaningful amount without putting either the mother or baby at risk, it would be a huge cost savings to the system not to mention the benefit to the infant’s health and long-term development. . . . I can’t handicap the chances of an approval next month given the panel’s recommendation, but it could be 10% or more. Under the assumption that there is a 10% chance the stock will be 4/share if they do approve it and 90% that it will be $0.60 if they require another trial (i.e. about 2 x cash for this cash flow positive, profitable company with a growing revenue stream), you get a fair value of $0.94.’