FDA has already delayed once by 3 months, why should they delay again, how much time do they want ? OREX has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Contrave® outcomes trial. The LIGHT studies met the specified endpoints, so FDA is obligated to approve. Besides the reason for delay was to discuss post-marketing obligations, discussions around the package, nothing that approval was in question. With Arna and VVUS already approved, there is no reason for FDA to deny Orex approval esp when it was the first weight loss drug to get a positive FDA vote and the first one to conduct a large pre-approval Cardiovascular trial.
Orex is very well funded has more than 100 million in cash, then is entitled to $100 million from Takeda after approval, European approval is a decent possibility coming Oct/Nov. So lot of positive things in horizon for Orex. I would not over think this and see no reason to start getting fearful
He certainly dose not inspire any confidence. But for his antics the stock would be at least around $6
Good move, and smart trading, Wish I was that nifty, but I have a full time job, difficulty to cater to hour by hour gyrations of the stock
All this is good, but the stock is going nowhere. Wonder if there will be any run up at all to FDA decision.
In DEC13 filed 510k seeking FDA marketing clearance for breast pump and patient collection kit after removing breast cancer genetic test from US market in OCT13 on FDA concerns over instructions, promotional claims and changes to collection device
- In late AUG14 submitted additional info to FDA including data from a multi-lab trial w/ 100% successful collection & processing rate, a study w/ reference panel specimen comparisons including 99% success rate, analytical study to show new specimen processing method is comparable to previous method & product stability data w/ FDA reply and/or decision exp by late 3Q14 (30-day review exp by FDA which may request more info or issue decision)
In late JUN14 received international quality management system certificates (ISO) to support ex-US expansion efforts w/ distribution partners including a CE Mark (Europe) that is expected during 3Q14
Also developing NextCYTE test for newly diagnosed breast cancer & ArgusCYTE for breast cancer survivors with a US product launch goal of 4Q14-1Q15 pending successful development & FDA marketing clearance
From Oct 2012, had 460,000 mnkd shares at one point, sold before Adcom. Then bought back 338,000 shares before Adcom sold after it, then bought 117,000 shares week before partnership and sold on pop on Monday. In addition have traded about 100,000 call and put mnkd contracts since Oct 2012.
If a stock is below $1 for 30 straight trading days a deficiency notice is issued by Nasdaq to regain compliance in 3 months. ACST is still about 10 days away for continuous sub $1, if the trend continues it should get a 90 days to comply notice in which to regain compliance the stock must above $1 for 10 consecutive days. Another 90 day extension can be granted if the stock meats any of the following "core" National Market initial listing criteria:
$30 million in equity;
$75 million in market value of listed securities;
$75 million in total assets and $75 million in revenue in the most recently completed fiscal year or two of the last three fiscal years; or
$15 million in equity and $1 million in income from continuing operations before income taxes in the most recently completed fiscal year or two of the last three fiscal ye
So delistment if the PPS remains below $1 would be in Dec at earliest but probably March as ACST seems to meet the "core" criteria. At that time to avoid delisting, a reverse split is an easy way to avoid it but usually at the cost of PPS. Getting delisted to OTC/Pink sheets can drop the stock price but is not a death sentence, stock can recover and PPS can go up if company generates results