You are still out of Cemp right? .All you do is complain about the Gonorrhea trial. You must be a cranky old man. I do not even think you are a doctor. The spike i mention is coming due to news coming. Any bacteria issues hitting the news is just icing on the cake if it is bringing attention to Cemp. Now go to early bird dinner and then to sleep at 9pm
A deadly bacteria that can be picked up by a simple sniff can travel to the brain and spinal cord in just 24 hours, a new Griffith University and Bond University study has found. The pathogenic bacteria Burkholderia pseudomallei, which causes the potentially fatal disease melioidosis, kills 89,000 people around the world each year and is prevalent in northern Australia and southeast Asia.
Should be good for $7 pop at least. Held down with IBB all yr.
Wow. You made no sense what so ever. I know the difference between the two and why they trade the way they do but you do not deserve the knowledge. For others reading this, the chart looks really sweet heading down the home stretch. I think news is coming but even if it dosnt come in the next week I see the break out over 20 coming real soon. I can just sense it.
Cemp is on the move
Yes. They should. Reserve is called "stewardship". Not to build resistance strains to treat small infections. As for the doc's, some penguins do not want to be first in the water and as crazy as it sounds....some will never go in the water. I know a urologist who swears he hasnt had a side effect from FQ's. Of course a uroligist dosnt have to fear death of macrolide resistance. He said he loves them. Most Docs are clueless that it is actually happening. Most will all get on board in time. In quick order Soli will have a huge part of the pie.
Empirical therapy is paramount especially in the older and very ill patients. No doctor will take a chance with these patients so either Soli or Lexo will be given if it is in the community setting. No doctor wants someone to die on their watch. Healthy, border line patients may very well get something else as you say because Soli will be reserved for only serious infections as it will be the best,more potent antibiotic on the market. Soli only needs 15% of each market it will be indicated for to be a bilion dollar drug.
Assuming the FDA finds everything acceptable, they decide if the NDA needs a standard or accelerated review, and communicates acceptance of the application and their review choice in another communication, known as the 74-day letter. In Cemp's case it will be a 6 month accelerated notice in a couple of weeks. Cemp may couple that news with other news IMHO and Cemp will soar. Peer review etc.
FDA evaluates the application within the first 60 days of its receipt to determine if it is sufficiently complete to conduct a full review. If FDA determines that the application can be filed (i.e., the application is sufficiently complete), the application review continues. Under PDUFA III, FDA agreed to communicate to applicants any significant review deficiencies identified during the filing review by day 74 of the review cycle.
Lots of news to stun the shorts coming. We are at the finish line and I wouldnt want to be short Cemp starting in July. Once they have loaded up they will let her fly. Soon
Thanks...I do need to chill a bit. I just see a future stock/bio market where Cemp may not be priced fairly and so Cemp needs to market Soli perfectly early on. GLTUA
OK. She has brought Soli a long way and deserves props. I believe she is an honest lady so I am holding. The problem is that she has fumbled the ball quite a few times . I wont harp on the details as we all know them. I think it may have gotten to the point where she is to emotionally tied to Cemp. I do not feel it is right to start slow,with a piece meal sales force. It is not fair to share holders. This is why the PPS will not move. The first 6 months will be slow. Its a drain on all of us. If she has a good offer she should take it. I first thought she was a crafty, master of negotiating but I fear now that she is just bungling again. The PPS will be depressed until sales are proven unless she supports shareholders with the right,strategic statements....or....maybe she may surprise us all with a sale in December. I big pharma would be killer with Soli. They would make Levo look like boric acid to the public and then the Docs ( payers etc)would be forced to pay up,(as they should anyway). She is to nice to play hard ball.
I was the first to say they were leveraging for a higher premium. After listening more closely I feel that big pharma may have a Ketek fear and want to wait 6 months to buy Cemp. The good news is that the longer they wait to buy Cemp, the more they will have to pay. Cemp could get a huge pop if the partner is a huge pharma as it probably means it will be them that buys Cemp after they feel comfortable. They may even chip in some $$ for marketing. The key is getting the public to know what effects that Levo can have. The Docs will then have no choice. If they would have just gone up against Levo we wouldnt be concerned right now. Im pretty sure Soli would have had significant efficacy going head to head.
Just read this. Sounds like me talking. Even their concerns on management the know the drug will sell its self in time.
After attending the company's investor day, Needham analyst Alan Carr says that he expects Cempra to have moderate success in commercializing its Solithera independently, due to challenges for a biotech company in penetrating urgent and primary care. However, and despite believing that the commercial opportunity is probably larger in hands of Big Pharma, the analyst thinks the company's share price does not reflect what Cempra can accomplish independently. He reiterates a Buy rating and $48 price target on the shares.
I always thought she was leveraging for a buyout but now I am not as sure. I am at 40% chance at just after approval. 75% at mid next year after Soli proves no side effects for 6 months.