Biotech Stock Mailbag: Amarin or Arena Takeout?
Good point. Even if Ampio's CEO and CSO do extend their lock-up agreement for another six months, plenty of other company insiders remain free to sell millions of shares starting July 15.
James asks, "Any chance you are going to take another look at Nymox Pharmaceuticals(NYMX) ?"
Nymox remains opaque about the clinical development of NX-207, its experimental drug for benign prostatic hyperplasia, or enlarged prostate. When I last wrote about Nymox in February 2011, CEO Paul Averbeck told me he expected to file NX-207 for FDA approval in 2012, assuming the ongoing phase III studies were positive.
But since Nymox doesn't provide any meaningful updates about the progress of the phase III trials, it's impossible to say whether the company is on track to meet its development timelines for NX-207. I have my serious doubts, particularly since Nymox has never disclosed much about the drug, and what it has disclosed makes little sense.
Why trust a drug company unwilling to be transparent with its shareholders or potential investors?
Andrew I. asks, "Will Chelsea Therapeutics(CHTP) ever recover? Lost half of the value today and have to do a new study. Down to about 85 cents today. Think a lot of the bad news was already priced in and that this news is really not a surprise. I can understand why the company would try to re-work their current study 306B but not surprised at all the FDA said no deal. What are your thoughts?"
Chelsea makes me sad. I believe Northera is an effective and beneficial drug for neurogenic orthostatic hypotension (NOH) patients but the drug is trapped, unfortunately, in FDA review purgatory by an incompetent management team. Chelsea isn't likely to recover until the company and FDA reach an agreement on how to collect the clinical data necessary to get Northera approved.
At this point, it's a legitimate question to ask if Chelsea's current management has the capability of finishing the job they've bumbled so badly to date. FDA should shoulder some of the blame for being recalcitrant with a drug that received a positive vote from an outside advisory panel, even if the margin of victory was small. Still, Chelsea's problem stems mainly from management's decision to amend -- and amend again and again -- the Northera clinical trials to the point where data collected are impossible to interpret.
--Written by Adam Feuerstein in Boston.