@adamfeuerstein hows bout a quick take on $CHTP advisory panel. I believe you were unpleasantly surprised by the last outcome— dino perlman (@DinoPerlman) October 9, 2013Let me start by recapping my recent history with Chelsea Therapeutics ( CHTP) and Northera, the experimental treatment for neurogenic orthostatic hypotension (NOH) -- a chronic disease characterized by dangerously low blood pressure. I predicted a positive vote from the experts on the February 2012 FDA advisory panel. Despite a highly skeptical FDA review and some really hairy Northera data, the panel voted 7-4 to recommend the drug's approval. Yeah for me! The positive panel vote prompted me to follow up with a column titled, Five Reasons Chelsea Therapeutics' Northera Will Get FDA Approval. And then FDA rejected Northera in March 2012. F---k me. Here we go for round two. Chelsea is bringing Northera in front of a second FDA advisory panel on Jan. 14. Like the last time, the panel experts will be asked to weigh in the risk-benefit of approving Northera for the treatment of NOH. Unlike the last panel, Chelsea arrives this time armed with more Northera clinical data from a second phase III study which the company hopes will convince the panel AND the FDA that the drug deserves approval. Let's dig into some of these new Northera data and discuss the issues likely to come up at the Jan. 14 panel. I spoke with Chelsea CEO Joe Oliveto this week to get his take as well. First, my prediction: The FDA panel will vote to recommend Northera's approval. The vote will be more decisive in Northera's favor than the last time. I'll hold off on predicting the FDA's ultimate decision (due Feb. 14) but if the panel goes well for Chelsea, it will be more difficult for the agency to say no a second time. The following slide describes the primary endpoint of the two phase III studies evaluating Northera in NOH patients:
@adamfeuerstein How long is overall biotech beating going to last? Big woodshed by Berger's new HQ. Cruel.Adam. Sold Aria in 20s TG.— Biobottom (@Biobottom) October 31, 2013Let's take another look at the biotech stock bubble. IBB data by YCharts
I snapped this chart on Thursday afternoon at 1 p.m. EDT. The biotech sector's underperformance relative to the S&P 500 has magnified a bit since I last posted the same chart nine days ago. Anecdotally, I still hear from many buyside investors who are taking risk off and selling winners into the end of the year. Ariad Pharmaceuticals' ( ARIA) implosion has almost certainly hurt biotech sector sentiment. The temporary removal of Iclusig from the U.S. market reminds generalist investors that biotech risk can slap you in the face at any time. ARIA data by YCharts
On a related note, WyanPL asks: Do you think Iclusig will ever get back on the market? If it does, maybe Ariad is worth buying? Ariad executives sounded very uncertain about Iclusig's future on Thursday's conference call, partly because the company doesn't yet know what the FDA intends to do, or what regulators will require before the leukemia drug is allowed to be marketed again. The possibility of FDA forcing Ariad to conduct another clinical trial as a prerequisite to Iclusig's return is even on the table. The heavy selling in Ariad Thursday -- on top of a month of soul-crunching selling already -- reflects the uncertainty. When Ariad executives spend most of the time on a call saying "I don't know" or "Um...", investors tend to run for daylight. Iclusig is a "dirty drug" with some scary toxicity, but then, patients with chronic myeloid leukemia (CML) unresponsive to all other therapies are going to die. My best guess is FDA allows Ariad to continue selling Iclusig but only as a last-ditch treatment for CML patients, most notably those with the T315i mutation. I have no idea when Iclusig returns but it won't be an overnight decision. We could be looking at months. I asked a hedge fund manager source to help me estimate the market potential for Iclusig if used only in T315i CML patients.
@adamfeuerstein $AMRN taught me not 2 believe the hype of biotechs, remove bias and the facts become much clearer. I thank u 4 that Adam.— Joe Morgan (@jmorgrain) October 29, 2013Thank you.
@adamfeuerstein you are a big joke with your ignorant articles $CPRX— BuySellStocks (@RookieStocker) October 23, 2013Thank you, too! -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein