Here is Adam F on CLDA "Wall Street hedge fund source who happens to be one of the smartest neuro-pyschiatric drug analysts I know is shorti
Giant scam. Deja Vu here is the Adam F article that drove CLDA to $13 "Wall Street hedge fund source who happens to be one of the smartest neuro-pyschiatric drug analysts I know is shorting CLDA" SAME PATTERN....Sound familiar?
The smartest guy he knew was wrong - (it was approved by the FDA first shot and CLDA more than doubled and was sold to Forrest Labs for $30+CVR) after approval this article predicted wouldn't happen)
Clinical Data: The FDA Bear Thesis Explained --by Adam Feuerstein-12/14/10 - 10:28 AM EST
NEWTON, Mass. (TheStreet) -- A Wall Street hedge fund source who happens to be one of the smartest neuro-pyschiatric drug analysts I know is shorting Clinical Data (CLDA) on the belief that U.S. regulators will reject the company's antidepressant vilazodone on or before a key Jan. 22, 2011 approval decision date.
"Vilazodone is a marginally effective antidepressant that is trying to gain approval into a crowded, genericized class of drugs in which many of the generics are, in fact, better," said the analyst, who works for a fund that doesn't allow its employees to be quoted by name in the media.
Clinical Data conducted two, phase III studies of vilazodone, both of which successfully met their primary endpoints. Isn't that enough to get the drug approved by FDA?
"Clinical Data did the bare minimum clinical work necessary to get vilazodone approved," the analyst says, adding that the lack of a robust data package including marginal efficacy data and no studies comparing vilazodone to active, currently marketed antidepressants will give FDA reviewers the clinical justification needed to reject the drug and request at least one additional pre-approval study.
"I give vilazodone a 35-40% chance for first-pass approval," the analyst says. His short position is predicated on the low probability of a vilazodone approval as well as a fully diluted market valu
I give vilazodone a 35-40% chance for first-pass approval," the analyst says. His short position is predicated on the low probability of a vilazodone approval as well as a fully diluted market value for Clinical Data of around $750 million when convertible debt and stock warrants are included.
Sell-side analysts are taking a much more optimistic view of vilazodone's chances with FDA. Wedbush's Greg Wade advised clients in a Nov. 10 research note that, "Based upon the strong trial data, promising safety/tolerability profile, precedent for the two mechanisms of action, and the fact that vilazodone is the first drug for depression to have success in its first 2 Phase III trials, we believe the drug has an excellent likelihood of approval, and the stock at $18.85 a share has a favorable risk-reward profile to our $28 price target."
The short-selling analyst contends, however, that a key secondary endpoint in the trials, the Hamilton Rating Scale for Depression (HAM-D) is the more relevant measure of vilazodone's efficacy because it is what FDA and most psychiatrists traditionally use to assess antidepressants.
Using the HAM-D scale, vilazodone showed a 1.8-point and 1.6-point improvement over placebo in the two phase III trials. The difference was statistically significant so technically positive. However, any improvement under a 3-4 point difference is generally not viewed as clinically meaningful, contends the analyst.
"HAM-D has a longer history than the MADRS, therefore FDA reviewers are more comfortable translating the effect size with clinical relevance," he says. Clinical Data designed a trial that was large enough to detect a small difference in HAM-D with statistical significance, but that just magnifies the marginal efficacy of the drug, the analyst adds.
See investor village ziop board for full article
"Generally, FDA likes to see data on a range of effects at different antidpressant doses," the analyst says. "With data on just a single dose, FDA can't determine what would happen, for instance, if a doctor doubles a patient's dose of vilazodone because the 40 mg dose was ineffective. The FDA also doesn't have enough data to determine if 40 mg is the lowest effective dose of the drug."
The overall clinical view of vilazodone painted by the analyst is of a drug which doesn't improve depression in a clinically meaningful way against placebo and has not been evaluated against competing antidepressants. Clinical Data has not performed the clinical work necessary to convince FDA to approve the drug at this time, which is why the analyst is short the stock
"Clinical Data did the bare minimum amount of work necessary to meet FDA's approval requirements," he explains. "It's like your editor asking you to write a 250-word story and you write a story that stops mid-sentence because you reached 250 words exactly. If you did that, your editor and your readers wouldn't be happy and neither will FDA with the vilazodone data."