Cempra Inc. (NASDAQ:CEMP)

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  • shoredriver: $CEMP climbing up almost8%
  • SusanW: @shoredriver $CEMP Do you feel there is any possibility for this stock to recover?
  • shoredriver: @SusanW $CEMP not sure what you mean recover...it is just squishy at this point....
  • Lou: @SusanW $CEMP - I am, unfortunately, very familiar with the company, its antibiotic and I believe that I have a good understanding of the FDA pronouncements and ongoing issues. Fortunately, I bailed right at the beginning of the drop and got out, with a massive loss, at around $10/share. My losses are so substantial that I have the dubious distinction of being one of the lead plaintiffs in a class action lawsuit. The founder, moving force and former CEO has retired. IMO there is almost no likelihood of any significant recovery. At best the antibiotic will be approved with a Black Box warning. I'm sorry to post this and wish all involved good luck.
  • mopick: @Lou $CEMP Shared your pain in this one! Too bad, too, as there was so much potential. Meantime, what's your take on the $ETE/$ETP situation now that Blackrock is supposedly out of the picture?
  • shoredriver: @shoredriver $CEMP Had an old moment and thought you were posting about$NVDA....$CEMP I am up almost 30% in aprox 3 weeks.....I treat it as an option that will likely not go to zero but could easily double or so if it gets approval....
  • Lou: @mopick $CEMP $ETE $ETP - watching and waiting. I'm still carrying a significant short term gain and am willing to risk some for what I perceive as some upside.
  • shoredriver: @SusanW $CEMP It appears that they will be doing a wider sample to get approval, where they are on that I will leave up to the various experts on this board.. Again, I am treating my investment as an option (LEAP) with likely nominal downside and large upside . You need to determine for yourself if you should sell ( along with tax advisor) and take loss or hold or add or whatever...
  • Lou: @shoredriver $CEMP - if I recall correctly the sample required by the FDA is 9,000. That would take about forever to enroll, let alone administer. IMO the stock will fluctuate like any low priced stock on the basis of rumors and conjecture - but recover? - not likely. edited to substitute word "enroll" for "gather."
  • bsafriet: @shoredriver $CEMP I'm holding my existing position, admittedly not much more to lose from here. I held on on the premise that they would get approval. I'm optimistic that they will complete the trial with the 9000 patients and resubmit request for approval. However I do not think. That they will be able to do this on their own. They will have to partner with someone or give a venture capitalist a big junk of the company. Their drug is desperately needed, there is a market. I was shocked that it was not approved with a black label. Unfortunately this one now is a long term trade.
  • Lou: @bsafriet $CEMP - for anyone holding this, and may have gains in other securities, I would suggest that the losses be taken to offset taxable gains. It's better to take them when they are still short term. I was fortunate as my losses offset a portion of my much bigger gains in Relypsa in 2016. Short term losses can be used to offset some other income (not trading related) as well, and unused losses can be applied to other years. If carried too long the losses become long term, a lot less valuable because long term tax rates are lower,
  • shoredriver: @Lou $CEMP And should they join the lawsuit then also?
  • Lou: @shoredriver $CEMP - no need. It's a class action, covering all investors in the class. The lawyers needed a few investors who lost money as lead plaintiffs. If there is a recovery all who qualify in the class will participate in the settlement or award.
  • shoredriver: @Lou $CEMP Well Investment, Tax and Legal advice all for free....very interesting.......
  • Lou: @shoredriver $CEMP - the advice is worth what you paid for it. That said, I'm retired from my law practice and have always been tax oriented as my first degree was in accountancy.
  • shoredriver: $CEMP up almost 30 % in 3.5 trading days
  • shoredriver: $CEMP at HOD up 6.5%
  • SierraJW: @shoredriver $CEMP Although one upgrade has been made, several others are still low, and I am looking to get out of $CEMP - I would not recommend staying with it - Very high risk, IMHO. (my losses are not the reason, the future looks VERY risky!) you may want to check it out at investing.com or finance.yahoo.com.
  • shoredriver: $CEMP.....Almost 5 bucks a share in cash and nominal debt plus patents. The antibiotic did not truly fail, the study was not large enough and they need to moderately upgrade the mfg plant....Seems to me like this could provide significant upside(2-3 bagger) over next 1-2 years...esp if a larger entity takes them out....
  • indigo1948: @shoredriver $CEMP - I agree with you on the impact of the study - target group needed to be larger - and on the potential. This one could be quite rewarding for the longer term investor but patience will be in high demand and the only question in the biotech area is whether there are more appealing upside stocks that look to have shorter term gain potential?
  • shoredriver: @indigo1948 $CEMP well if the stock moves back to cash value that is almost a double and any good news/buyout would likely send it way above that...so I guess I would take a double (or way more )in a year or three any old day of the week...
  • indigo1948: @shoredriver $CEMP - hard to argue with that math - I am looking at it tomorrow and thanks for the comments.
  • steve71: @shoredriver $CEMP Let me offer an alt view: 1) Cash. Yahoo is not current. Last week the CEO stated cash was $230M. Debt is $17M. With 52M shares, cash is $4/share Cempra's burn rate is $100M/year. 2) FDA wants a 9,000 patient study before r ...
  • shoredriver: $CEMP....anyone else playing? I'm up about 24% from yesterday....think I will let it roll into next week....
  • jnag698: $CEMP- .................... KABOOM!!! Another biotech bites the dust, as the FDA rejects Soli. Personally, I think one can make more money shorting biotechs.
  • tejas7: $CEMP this came in my morning mover scan. Going in dumps after FDA
  • steve71: @tejas7 $CEMP Pretty much a disaster. FDA wants a 9,000 patient study before resubmission of the drug. Sounds like approval would be quite restrictive at that point. THEN FDA wants a post-approval, or P4 study. The economics may kill the drug, if not the company.
  • tejas7: @steve71 $CEMP Market thinks may be death of company
  • SusanW: @tejas7 $CEMP This was my 2016 lesson. Don't go down with the ship. I mistakenly thought this was going to get approval and stuck with it. Now I guess I'll finally sell and buy a sweater to remind me of my loss.
  • tejas7: @SusanW $CEMP Tough luck! I stopped playing with these "approval" trades. I think I need a mole in FDA to make money in these trades. And they have made it illegal to do so..:)
  • Henry: $CEMP The FDA has set the target date to take action under the PDUFA as December 27 for the oral formulation of solithromycin and December 28 for the intravenous administration of solithromycin.
    The Drug
    Solithromycin, according to the company, ...
  • 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
  • :
  • 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?
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Stock Price $USD 4.30
Change 11.69%
Volume 2,195,230

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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