Cempra Inc. (NASDAQ:CEMP)

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  • steve71: $CEMP Cempra is down 13% today after SunTrust changed their rating from Buy to Sell. Or maybe it was the predictable class action suit filed same day. Cempra's drug Solithromycin, for CAPB, has a PDUFA date of 12/27. About 20-30% of Community Acquired Bacterial Pneumonia cases involve a resistant organism. Solithro is a needed alternative. But Cempra lately said that Solithro causes liver damage in some people. Hence the 65% drop on 11/1/16. So the 12/27 (or sooner) decision is a lottery ticket. As others have mentioned, Black Box approval seems likely, and should bump the PPS. No position, but I'm tempted to buy a few shares. Or maybe I'll go to the corner liquor store and buy ACTUAL lottery tickets.
  • TRICIA: $CEMP .... buy a bit rhrn .... FDA pdufa due EOM .... will it have a black box ... yea... but tylemol cause s elevated liver enzymes too. Will it get a CRL ... I doubt it... we don't have a reliable CAPB drug to send folks home on ... just my thoughts ...
  • jnag698: @TRICIA $CEMP - THE Tricia??? wow! Welcome back. Always enjoy ur posts. Agree about CEMP's Blk Box & CRL.
  • Marcelomex: @TRICIA $CEMP you are a holiday present!!! Welcome.
  • rj7150: @TRICIA $AKAO Nice to see you back here! The one thing I have noticed is that it isn't easy for some of these research companies to go from stage 3 success to profit from sales. Many of them seem better served to sell to a big dog that has a sales department, distribution etc in place. I sold yesterday to soon after a long underwater hold. I lost control when It went green. I only have a couple dogs left, one being $CEMP.
  • shoredriver: $CEMP looking perky....
  • JJT1: $IBB $TEVA $ENDP $CEMP $ALXN $ACAD Took opportunity of big jump in Biotech to put stop limits on several bad trades so back to B/E.
  • shoredriver: $CEMP If it reaches 5 ish I am a buyer....
  • GOOSE: A TRADE: Surprised me. $CEMP STC STOCK @8.92 Near the open. Actually made some $. Small position.
  • rj7150: $CEMP - With the results from Fridays AdCom, what will happen to the stock price of Cempra going forward? I was traveling Wednesday when the Wiley Coyote move occurred and am still holding the smoldering remains of a half position.
  • SusanW: @rj7150 $CEMP were any results posted yet? I haven't seen it
  • janner0814: No position.... got some time before heading out to #WORSHIP, to look at the $CEMP chart, in my 4 time frame perspective..... Here is my "non-editorialized," #TECHNICAL graphical #ASSESSMENT of $CEMP: http://tinyurl.com/cemp20161104janner BTW: Each of the four #TIMEFRAMES, presents #COMPELLING #QUESTIONS. #QUESTIONSareETERNAL. Also, pay special attention to the #DAY chart; as @Aragorn would probably say: "Inside days (the "low harami")" at #INFLECTION points can have powerful & #FAST moves (to either way)...... so it's important to let the #CHART #UNFOLD. Be Patient. Be Observant. Be Water. @SusanW $CEMP
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  • janner0814: @rj7150 Better than relying on $CEMP news that is already factored in... http://tinyurl.com/cempra20161106rj7150 Enjoy your #HashBrowns #SmokingHash to ease your #PAIN. ***************** #PAINFULwiseARSE 😣 #OUCH #VIX #ALERTS #graphic #WEEKLY #UNFOLDIINGS #jannerCAUTIONARY #WAITING #SIGNS #TELLS #POTENTIAL #QUESTIOMSareETERNAL #setups #cash #WAIT #NOTRUSHING #LETMARKETUNFOLD #HashTag #HashMarks
  • PhilHarmonic: @rj7150 $CEMP This is a busted stock that you would do well to stay away from.Massive institutional selling last week.Everyone who has bought and held since 2014 has lost money. Follow Dan's advice and stick with the winners.
  • SusanW: @rj7150 $CEMP #1 #2 #3 Thank you! I didn't see that. I have a long position ( unfortunately) but this outcome sounds promising. Obviously the chart is horrible, but I could not believe the years of trials would not have turned up a huge flaw to prevent this drug from coming to market. I guess we will see
  • SusanW: @SusanW $CEMP #1 #2 #3 Sorry , I read the last post incorrectly. At first glance I thought it was 12 yes for adequate study. Doesn't look good.
  • janner0814: @SusanW $CEMP #1 #2 #3 Why? The SA "bad news" is already "baked in the price." Might be wise to.look more at price action. Look at the 4 time frame chart I have posted. http://tinyurl.com/cemp20161104janner Sellers running low on momentum? Perhaps?... you MIGHT have opportunities to unload it at better prices..... & maybe not.... ##LEARNINGexperience
  • shoredriver: $CEMP halted due to drug review...Looks to be halted most of /all day...
  • jnag698: $CEMP- twitter listing split vote on adcom..........7- yes, 6-no.................FWIW
  • steve71: @jnag698 $CEMP The concern about induced hepatitis really hurt. My guess is that the full FDA panel will issue a very narrow approval as well. Possibly use limited to hospitalized patients, demonstrated to have otherwise resistant organisms. And a P4 study may be required to gauge long term hepatic damage and survival. The limited label would hurt sales, if that happens. Ironically, Cempra is recruiting a study using Solithro to TREAT hepatitis. ClinicalTrials.gov Identifier:NCT02510599. Since the drug can cause liver damage, sounds like a non-starter. Fascinating story. IMO it's a coin toss, not an investment.
  • JJT1: @skyrunner $ENDP $TEVA $VRX Thanks for info. And I thought yesterday news re: $CEMP was the worst day I ever had.
  • Lou: $CEMP - OUCH!
  • woodman: $CEMP #Biotech - Example 3,829 of "great biotech" turned biosh** and why not to hold small and midcap biotech. It's been an inexcusably long learning process for me, but I (think I) have learned. I've been pretty unlucky too many times getting caught holding biotechs, but thankfully I saw the writing on the wall, respected my bad experiences, and sold down to a 10 share marker in CEMP. Likewise, I sold virtually all my other biotechs (I have some marker positions in a few bios, but that's it). I'll wait for this poorly performing sector to revive (who knows how long that will take) and when it does, will likely only trade in the broad biotech ETFs.
  • jnag698: @woodman $CEMP #Biotech - VERY GOOD point. My question, as I have traded stock/ options around in the past, is what happened?
  • woodman: @jnag698 $CEMP #Biotech https://endpts.com/buffeted-by-safety-fears-cempra-shares-plunge-as-investors-assess-an-fda-review-for-its-antibiotic/
  • jnag698: @woodman $CEMP #Biotech - Thanks. bummer.
  • gwenzee: @Lou $CEMP Problems with India might have been worked around. But, rise in liver enzymes and injection site related problems not so much. Don't think AdComm will vote favorably at this point. OUT and thankfully just had a starter position.
  • Lou: @gwenzee $CEMP - out with a very large loss.
  • shoredriver: @Lou $CEMP Well at least you can use it against all that $RLYP gain for Uncle Sugar...
  • woodman: @Lou $CEMP Sorry, Lou. I hope you bounce back soon! Seems like for every biotech winner there are many more losers. At least in my personal experience.
  • mopick: @Lou $CEMP Sorry, as well, Lou! Small biotechs are just lethal. Been burned myself in the past, never again!!
  • Lou: @mopick $CEMP - thanks to all sympathizers. I am glad I got out about 2 points ago. Proves that sometime brass ones get squeezed by forces stronger than brass. I'm in the largest cash position that I've been in for several years and still carrying a very large taxable capital gain for the year. No complaints.
  • SusanW: @gwenzee $CEMP I was blindsided by this disappointment. How could this liver problem not show up in all the trials that have been performing? The company was talking about circumventing the India problem by using Mexico, and not a peep about not being able to go into production at all. I am really disgusted.
  • gwenzee: @SusanW $CEMP A lot of us were blindsided. If it does get a thumbs up from AdComm and it soars (fat chance) how disgusted will we be then?
  • JJT1: $CEMP now the attorneys are looking into lawsuit against management. Unwound my try at mambo combo strangle. Didn't lose the farm but it is smaller.
  • DavidM: @gwenzee $CEMP Well I need to tattoo it on the back of my hand. Stay out of these suckers. But I did buy blow $50 on a cheap November call option just in case it is approved and pops. :-(
  • gwenzee: @DavidM $CEMP If, if, if you pick the right ones it can be very lucrative. Made very good $$$ in MDVN, GILD, SRPT, TKMR JUNO, ISRG. But, if it tanks it's a big ouchie. CEMP was a big ouchie. Problems surfaced so late in the game that no one had a chance.
  • woodman: @JJT1 $CEMP - the CEO looks like she touted innocuous intravenous soli toxicity but held back on troublesome info about toxicity with the oral version of soli. When I saw the news on the AdCom documents this morning, I figured the first lawsuit Complaints would be filed by end of the day.
  • steve71: @woodman $CEMP Bad gnus. But I bet that FDA wants this drug. Outpatients who are macrolide resistant will otherwise wind up in hospital getting IVs. Plus maybe an ICU stay with a vent. Solithro is necessary. FDA may well expedite approval of the Mexican plant. There is an additional concern for the AdCom. The M.D.s on that panel are super scientists and clinicians. They know that Erythro and then Azithro induced resistance because they were overprescribed. (Who hasn't had an Azithromycin 500mg 3 Pack?) The panel could well recommend that Solithro be approved ONLY for patients who have culture proved resistance to older drugs. Since that is just 20% of the U.S. population, the addressable market declines by 80%. Why get near this? Maybe something safer, like Venezuelan mining stocks.
  • woodman: @steve71 $CEMP I think until we get more word on the manufacturing issue, the stock is going to be hindered. Perhaps good news from the AdComm on 11/4 will give it a jump, I don't know, but can they really go forward with PDUFAs in late December - o ...
  • Lou: @gwenzee $CEMP - thanks for the consolation. Obviously your situation is much different than mine and I feel terrible about what you are going through. Who said that our age we will enjoy the golden years? Too many medical issues around for the years to be truly golden but then again we are looking at the grass from above and should be grateful. As for $CEMP, because I'm not as smart and nimble as @woodman, and because (even at my advanced age) I consider myself a long term investor, with a manageable full position, I'm holding. Whether in 2016 or 2017 I expect a very large payoff so I can wait. Not adding RHRN but when there is mors visibility I may well add.
  • gwenzee: @Lou $CEMP Definitely like looking down at the grass instead of up at the roots. Take care.
  • mopick: @steve71 $CEMP Horrific management failure not to monitor that Indian plant's inability to attain GMP practice. Really stunning IMHO. Good luck getting that Mexican facility approval before pneumonia season passes them by. Fortunately for them they have 250 mil in the bank, they're going to need it. I wouldn't touch this stock now.
  • JJT1: @issues $LITE $JAZZ $VRX I have big L on my forehead as I have $ENDP, $TEVA, $CEMP, and to prove I am not total biotech loser recently bought $NKE and $XOM.
  • issues: @JJT1 $LITE $JAZZ $VRX $ENDP $TEVA $CEMP $NKE $XOM You are a true friend for helping me today realize I am not alone. Thanks your help, I needed that. Reassurance! Encouragement! and HOPE! Are one of the best things I get out of the Forum members comments. Thank you one and all!!
  • JJT1: @issues $LITE $JAZZ $VRX $ENDP $TEVA $CEMP $NKE $XOM Well we (or I) are learning as positions are Small and have a plan to enter and exit. Or in my case 2 out of 3. Still learning on stopping out or exit.
  • Lou: @mopick $CEMP - totally agree. Didn't reply promptly as I am not spending much time online because I injured my back last week. Had a lot of pain but now getting things under control. It turns out that it isn't too severe and with continued rehab and excersize I may be able to avoid a shot or surgery.
  • woodman: $CEMP - one view on where things stand http://news.cmlviz.com/2016/10/28/cempra-inc-nasdaq-cemp-drops-on-manufacturing-issues.html
  • gwenzee: @Lou @Woodman $CEMP Buy, Sell or Hold??? I'm holding until Nov. 4 AdComm mtng. and then reassessing. Lou, sorry about your back. I know what back pain is and just had a Spect CT because of chronic pain. Orthopedic surgeon said only way of correcting problems was to fuse T-7 through L-5. Placing rods on both sides of spine and anchoring them to the pelvic area. 5-10 hours of surgery and 6-12 months recovery. Cried all the way home. Decided that surgery was not on my bucket list and am opting for pain management. Wish me luck. Growing old has its downside.
  • mopick: @Lou $CEMP What's stunning is the horrible execution by management. How did they not know that the Indian facility wasn't FDA compliant? Why can't Wockhardt make it in the US? They have manufacturing facilities here! Perhaps they could partner with someone else here so they don't miss out on the pneumonia season in the US. Having dealt with the FDA I know the delays & bureaucracy involved. Getting their Mexican manufacturer, Uquifa, approved for GMP takes a long time. Consensus seems to be that in the short run that Nov 4th Adcom could well be a nice catalyst , otherwise, longer-term, a really tough situation. They will likely need more $ or raise more stock to fund all the infrastructure they have in place in anticipation of their launch. Too bad, as Solithromycin seems to be such a winner!
  • mopick: @gwenzee $CEMP Their management royally screwed-up. How in the world did they not know in advance that the Indian facility was not GMP FDA compliant? That's stunning! Wockhardt has manufacturing facilities here. To get that Mexican operation compliant will take a long time. I've been involved with the FDA in the past & I can tell you it's super frustrating. They're now going to miss out the pneumonia season here which is a major blow. Maybe they could partner with another contractor in the US or take some other action, otherwise, it doesn't look good. Short-term catalyst as you noted might well be a good one in advance of the Nov 4th Adcom. Really too bad as Solithromycin seems like such a winner!
  • gwenzee: @mopick $CEMP You nailed it. That is why I mentioned it in a post yesterday (or was it Thursday???). Would be a shame if AdComm gives a big thumbs up and PDUFA is delayed because of manufacturing problems. Management should have Plan B in place before 11/4.
  • sincity45: @Lou $CEMP thanks to all for your responses.
  • Lou: Sorry about being a Pied Piper in cheer leading these forums into $CEMP. That said, I look at today as being a great opportunity to add (in for a dime, in for a dollar) so I added 10% to my holding at 17.94.
  • gwenzee: @Lou @Shoredriver @sincity45 $CEMP Started a position last week in anticipation of AdComm meeting voting in favor of new drug. Holding until then may be a dumb, dumb thing to do or really smart. Who knows? Biggest fly in the ointment seems to be Wockhardt in Mumbia. FDA import alert prevents any drugs manufactured there to be sold in the U.S.A. CEMP has other facilities for manufacturing drug but will that be enough?
  • Lou: @gwenzee $CEMP - the India manufacturing facility seems to be the problem. One can't predict AdComm precisely but it seems that the drug is needed, safe and doctors are anxious to prescribe. It seems that there is plenty of time between now and the targeted 2017-2018 pneumonia season for the kinks to be worked out so that all systems are go. I'm generally a patient long term investor and I guess the situation here will fall into that category for me. I still see this as an eventual $40 plus stock.
  • gwenzee: @Lou $CEMP We agree and we both have patience. They have really ramped up their sales force in anticipation of a a good outcome.
  • shoredriver: @gwenzee $CEMP Refresh me...that is on 11-4 ....TIA
  • gwenzee: @shoredriver $CEMP Drug AdComm mtng. is on 11/4. PDUFA dates are 12/27 for oral and 12/28 for injection.
  • woodman: $CEMP - biotech disaster de jour. Order from the menu by number. Comes with soup.
  • woodman: $AKAO - #6 on the biotech disaster lunch special menu, just below $CEMP.
  • sincity45: @woodman $AKAO $CEMP #6 Any news on $AKAO still holding a large position.
  • woodman: @sincity45 $AKAO $CEMP - not sure what went down at IDWeek this week. http://www.idweek.org/exhibitor-list/ Its plazomicin is in phase 3 for cUTI, with an NDA scheduled in 2017. But, specifically, I don't know what happened to drop it 25% in two days.
  • sincity45: @woodman $AKAO $CEMP Does the 200ma a better entry or take a nibble today. Thanks for your response.
  • debeers: @woodman $CEMP -You want fries with that? Healthcare is getting a hit from all sides: on the one hand we have a party determined to squelch rising drug costs and the other seems determined to eviscerate the HMO's. If you want to be in this space, why not let the dust settle and look into the folks who own the Medicare space.
  • woodman: [EDITED] @sincity45 $AKAO $CEMP Wish I could direct you. All I can say is that it is holding the 50 day now. But I don't know if this is trading technically or not, because I don't know if there is news driving it down. Particularly in the biotech world, news trumps technicals. If you decide to nibble, used today's intraday low as your stop reference (i.e. a stop a little below that). Personally, I'd prefer to wait until next week and wouldn't buy today. Sorry I can't be much help.
  • sincity45: @woodman $AKAO $CEMP You have helped plenty, took a very small position today and wait till next week to add.
  • captron: $CEMP - Is this a sloppy cup and handle I am seeing on the daily?
  • Lou: Another #BearRaid on $CEMP this morning ahead of earnings after Market today.
  • Lou: $CEMP facilty approval delays hammer shares AH. Darn!
  • Lou: $CEMP - so far down on low volume. Let's hope it gets back when market opend.
  • woodman: @Lou $CEMP - After a mental back and forth, I sold half my shares during the trading day today. I guess I should have sold all.
  • sincity45: @Lou $CEMP so what does that mean, please explain?
  • steve71: @Lou $CEMP That's not a huge deal. Sooner or later the manufacturing facility will be approved and running. Delays aren't great, but it's not worth a 15% after hours decline either. I currently have no position, but will buy tomorrow if opens tha ...
  • woodman: @steve71 $CEMP - I believe they have a facility in Mexico that they may be able to turn to. Not sure though. Looking at 6 month delay? Regardless, the 11/4 AdCom. should give plenty of excitement in the interim. Pretty hard to place any odds in the short term.
  • Lou: $CEMP is under attack by shorts. I just got an offer from Schwab for a loan of my shares.
  • maratom71: @Lou $CEMP#OT Is there any financial benefit to You, for lending Your shares? TYIA.
  • Lou: @maratom71 $CEMP #OT - yes, a paltry interest rate from Schwab. Other brokers, namely $GS offer far more but that's not where I have my shares.
  • SusanW: @Lou $CEMP Are people going short because they don't think $CEMP will get approval?
  • Lou: @SusanW $CEMP - not necessarily. Most of these raids are concerted efforts by short sellers to drive a stock price down and when they've driven it down enough for retail owners to panic sell, they cover their shorts. Then they do it again the following day. I've lived through these downs and ups with a biotech named Relypsa and ultimately it was taken out much higher. in the meantime the shorts made a lot of daytrading profits though many were probably caught with large short positions when the buy out occurred. Inasmuch nothing is likely to occur with $CEMP before the FDA actions, they can whipsaw retail holders. I'm holding and won't be spooked.
  • woodman: @Lou $CEMP - sitting on my shares. I may add more.
  • Lou: @woodman $CEMP - Good idea but I'm standing pat - I have enough shares to be very happy when it goes up and don't want to unduly worry when it does not occur on my schedule. Learned a lesson from the ups and downs of RLYP, which caused me a lot of concern but in the end was worth it. Good luck.
  • woodman: @Lou $CEMP Good point. I have those memories as well.
  • Lou: @woodman $CEMP - looks like shorts are covering into the close. They'll be at it again tomorrow.
  • :
  • martyrb3: $CEMP Big pump tease by Money Map services; last night was last chance to subscribe to find out. Seems very likely that it's $Cemp given clues and Nov 4th date. Up pre-market.
  • gwenzee: $CEMP Took 1/3 position today. Slight worry because earnings are 10/27 BMO. FDA commitee mtng. is 11/4 and 2 PDUFA dates 12/27 and 12/28. If all is positive could see a big breakout.
  • Lou: @gwenzee $CEMP - you should do fine with this. I added this morning to an over-full position and sold some puts as well. Good luck to both of us!
  • gwenzee: @Lou $CEMP What is your take on the upcoming events? FAD hasn't approved a new antibiotic for 30 years? Some have gone the way of the old sulfa drugs.
  • Lou: @gwenzee $CEMP - earnings not a factor and FDA should be routinely positive. Market seems to agree. My guess is a buyout in 2017.
  • mopick: @Lou $CEMP As a late comer to $CEMP is the thesis here simply the approval of 'Solithera"? I assume from what I've read they'd likely partner with someone else in terms of distribution. Am I reading this correctly? I've always been suspect of one-hit biotech, just so risky. Thanks, my man!
  • gwenzee: @mopick $CEMP I'm not Lou which is pretty obvious. CEMP, in addition to Solithera has other drugs in its pipeline. Phase 3 - solithromycin - urogenital gonoccal infections. Phase 2 - solithromycin - COPD and NASH. Phase 3 - Taksta - Acute bacterial skin and skin structure infections. It is not a 1-drug wonder.
  • Lou: @mopick $CEMP - I have nothing to add to to the excellent reply by @gwenzee. I believe that the best is yet to come and added 3 times today.
  • Lou: $CEMP - now up 2 pts from my opportune recent add. IMO will continue to move so it's not to late.
  • captron: @Lou $CEMP I added this morning and I thank you for bringing this to the forums attention.
  • woodman: @Lou $CEMP - added more this morning. Nice buy, Lou. You nailed it. Finally the run into 11/4 Ad Comm.
  • gwenzee: $CEMP @Lou @Captron @Woodman 11/4 is the date of FDA Antimicrobial Drug Advisory Comm. to discuss Solithromycin. PUDFA dates are 12/27 (oral) and 12/28 (intravenous). This could really be a game changer in the fight to find a new antibiotic as the older generation of drugs are not as effective as they once were. CAPB (community-acquired bacterial pneumonia) is the #1 cause of death from infection. 5-10 MILLION cases are diagnosed each year. Largest impact is on the very young and the elderly. No current antibiotic can fight CAPB. It is, in essence, a death sentence for most . NP but looks very promising.
  • steve71: @gwenzee $CEMP #1 "No current antibiotic can fight CAPB" I'm sorry, but that is misinformation. Pneumonia is common and is normally acquired in the community. Hospital-acquired pneumonia is more dangerous because multi-antibiotic resistant bacteria evolve there, and because hospitalized patients are already sick. CABP has gradually evolved some resistance. Patients are cultured and empiric treatment started. Treatment may be adjusted based on culture results. Most cases are successfully treated with a variety of available antibiotics. Cempra's antibiotic is needed and the panel is highly likely to be positive. But Infectious Disease specialists will use it as little as possible. Why? Because the more it's used, the faster resistance will develop. So the price will be high. If that is allowed.
  • Lou: Very opportune add to $CEMP yesterday morning. It is catching quite a bid. SA article today may be giving it some of the impetus. Now holding better than full position and waiting for buyout.
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Stock Price $USD 4.05
Change -0.61%
Volume 980,462

Cempra Inc is a clinical-stage pharmaceutical company which is developing antibiotics to meet critical unmet medical needs in the treatment of bacterial infectious diseases, particularly respiratory tract infections and skin and skin structure infections.

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