My bad. Briefing docs are already out:
fda.gov
Explains the wide swing in price today. Reuters with analyst color:
>>UPDATE 2-US FDA staff question Allos lymphoma drug data
Fri Aug 28, 2009 1:02pm EDT
* FDA advisory panel to review drug Wednesday
* Company says drug offers meaningful benefit
* Shares fall over 6 percent (Recasts; adds FDA, analyst comment; updates shares)
By Lisa Richwine
WASHINGTON, Aug 28 (Reuters) - U.S. drug reviewers questioned findings from biotech company Allos Therapeutics Inc (ALTH.O) on the effectiveness of its proposed drug for an aggressive type of lymphoma, documents released on Friday showed.
Allos shares fell 6.2 percent to $7.29 in afternoon trading on Nasdaq. The company is counting on the product, Folotyn, to be its first drug to reach the market.
Food and Drug Administration reviewers, in a summary prepared for an advisory panel, said their two issues with Allos' application were "the clinical significance of tumor response and duration of response" as well as "whether the benefit:risk ratio is favorable" for Folotyn.
Allos is seeking approval to sell the drug for previously treated patients with peripheral T-cell lymphoma (PTCL). There are no approved therapies for the disease.
The FDA reviewers said they would ask an advisory panel that meets on Wednesday for input on those issues.
Wells Fargo analyst Aaron Reames, in a research note, said he "remained positive" on the prospects for a favorable panel vote based on previous support for a cancer drug with similar data, a "robust response rate in a highly desperate patient population" and other factors.
He said it was "a significant positive sign" that there was "no language suggesting a concern with ... Folotyn's safety profile" in the FDA staff summary.
Allos, in a separate summary, said PTCL patients who have failed to respond to other therapies were "in desperate need of better treatment options." Folotyn "offers these patients a therapy demonstrated to induce clinically meaningful responses," the company said.
Allos reported that 29 patients, or 27 percent, responded to treatment with Folotyn. FDA reviewers, however, said the agency "cannot verify these responses and their duration in these 13 responders except that these responses lasted (less than) 14 weeks."
The input from the advisory panel will be key as the agency usually follows panel recommendations. A final decision on whether to approve the drug is due by Sept. 24, although the agency has missed several such deadlines in recent months.<<
snip
Note the PDX decision will come in the afternoon session.
I'll probably watch and see what the panel does. Then sell remaining volatility through sold puts after the dust settles. Though Reames point about "the prospects for a favorable panel vote based on previous support for a cancer drug with similar data, a "robust response rate in a highly desperate patient population . . . " is well taken. The bull spread now is tempting for instant gratification.
edit: thanks kenott; I'd found them two hours ago; just forgot to hit the final post button. Still no position. Trying to find lower risk plays these days. Looking to sell volatility where there's no actual event expected in the time period. I'd say the PDUFA date being so close to the panel date argues that any IV in the September options will be drained following the panel decision, cuz i think the odds of the FDA acting a week before the PDUFA deadline -- i.e. two weeks after the ODAC meeting -- are slim to none. Especially since the FDA has missed the majority of their PDUFA deadlines this year. But the stock will go wild one way or the other, and finding a decent entry might be tough. Probably not going to position until the end of next week.
Cheers, Tuck |
