bought ACRX after slaughter today (-60%) on FDA news; but, there's plenty of hope: FDA says "re-submit" - vol. 22M shares - everyone who wants to sell has probably sold. Oct 12 (Reuters) - Acelrx Pharmaceuticals Inc(ACRX) * AcelRx Pharmaceuticals(ACRX) receives Complete Response Letter from the FDA for Dsuvia™ NDA * AcelRx - CRL states that FDA determined it cannot approve NDA in its present form and provides recommendations needed for resubmission * AcelRx Pharmaceuticals Inc(ACRX) - confirm plans to move towards resubmission of Dsuvia NDA * AcelRx Pharmaceuticals Inc(ACRX) - AcelRx ended Q3 with an estimated $67.9 million in cash and we will provide further financial updates on our Q3 earnings call * AcelRx Pharmaceuticals(ACRX)-will request a meeting with FDA to discuss topics covered in CRL * AcelRx Pharmaceuticals Inc(ACRX) - received a complete response letter from FDA regarding its new drug application for Dsuvia, 30 MCG * AcelRx - in CRL, collection of additional data requested on at least 50 patients to assess safety of dsuvia dosed at maximum amount set in proposed labelling * AcelRx Pharmaceuticals Inc(ACRX) - in CRL, FDA recommended certain changes to directions for use to address use-related errors, including dropped tablets.
@fireopal - you get full credit for this: had a large ACRX position until you posted FDA deadline was 10/12 (today) - had a bad feeling and sold 95% @ $5.50 - so thank you!! wasn't paying attention and would have taken a major hit; instead bought on close and can only lose another $2.15 on the good side - they have lots of cash & confer. call after earnings will say they're working with FDA and blah, blah - this med should be approved next time because military wants it. BIG thx!
Thurs. watchlist gainers: JRJC: $2.42 +4% / JKS: $23.50 +4% / VEEV: 59.52 +4% / PLUG: $2.87 +3% / BRKS: $31.25 +3% / ZTO: $15.56 +3%
^^ glad i was able to help Did you see AAOI - big drop along with HMNY. PS just took a look @ ACRX - HUGE vol today & looks like sell off may be done - green now lol
AAOI - wow - earning's warning - $12 in AH - that's the problem with holding; probably a great time to 'scalp' - many disappointments coming at these levels. Not worried about China plays - it's the ones priced to perfection that i'm dumping & will buy back after earnings....don't have the stomach for HMNY - 40% in one day? doesn't feel like great earnings coming imo...
Went back to try to find ONCE post & i give up - too many posts here but pretty sure i did give some notice & apologize if i didn't becuzz >>> FDA Advisory Committee Unanimously Recommends Approval of Investigational LUXTURNA™ (voretigene neparvovec) for Patients with Biallelic RPE65-mediated Inherited Retinal Disease -https://finance.yahoo.com/news/fda-advisory-committee-unanimously-recommends-205135353.html watching >> SGMO (dip add to swing) - AAOI - INFI (up or down) - CLSN Adding - decided to check Adam F tweets & nothing negative on ONCE so can sleep now
China looks good: XRF +6% / BZUN +5% / SORL +5% / JMEI +3% also, keep an eye on ZNGA - creeping up a bit last few days... SIFY: $1.66 & CRMD: 0.65 both down - still like 'em both and buying more; ACRX holding $2.
little mine fields; but could be an opportunity after panic selling over; another bio: CARA: $12.66 (port. 2): new pain med - large hdge fund ownership - hasn't been under $13 for a while. 10/13/17: CARA Target Price Reaches $25.14 - Brokerage houses, on average, are recommending investors to buy Cara Therapeutics, Inc. (CARA)’s shares projecting a $25.14 target price. Cara Therapeutics Inc. (CARA) is developing lead molecules that selectively modulate peripheral CB receptors without targeting CNS cannabinoid receptors. Peripheral CB receptor modulators will be initially developed as a novel therapeutic approach for neuropathic pain, a condition currently without consistently effective therapies. Studies on the effects of cannabis (marijuana) have led to the recent discovery of an endogenous system of ligands in humans involved in a number of physiological processes including pain and inflammation.
Sheesh - ONCE had great news BUT fell below my entry price. Glad i saw AAOI drop yesterday b/c that took me right back into DO NOT HOLD mode!!
ICPT phase 2 results due soon & hope PPS moves enough so i can move this new designer bag out of my closet!!