1. CDC just relased a report and while MDR gram negative infections have been a huge and growing concern for the past two decades now, CRE was one of four infections noted to be in urgent need of new antibiotics. There are 9000 cases of CRE every year in the US alone, with over 600 deaths due to it per year in the US.
2. The comparator drug in the study, Collistin, is actually a VERY old antibiotic (from the 60's) that is amazingly now the last line of defense to save people's lives who have CRE. It is very renally toxic and the only reason that MDR isn't fully resistant to collistin yet is because doctors stopped using it for decades because there were safer drug options available, unfortunately all of those antibiotics are now ineffective as treating these hospital acquired MDR gram negative bacterial infections.
3. A superiority study in antibiotic drug development is rarely done, because frankly it's a very high bar to reach. Most antibiotic trials are simply non-inferiority. ISIS is going for a slam dunk here!
As an outsider here (no money on the line), I don't understand why this stock is dropping but I do feel that anyone who is long should absolutely hold out here. The approval and label was GOOD news. Even if the stock was oversold prior to approval, there is nothing to justify this much of drop other than uneducated investors who see the words warning and freak out. Once sales in, this stock is going up.... I'm very tempting to buy in today.
I don't believe in technicals either (other than the fact that they can sometimes be a self-fulling prophecy when people see a "breakout" and everybody goes all in), but case wasn't wrong this time.
Having met many of the managment at ISIS myself while interviewing for a job there (which I didn't get!), I can tell you they are not going to sell themselves short. They've worked 70+ hour weeks for years to build this company to where it's at now. They can be the next Gilead or Genentech.
Many/most of them are the same person, it's obvious based on their (nonsense) writing style and use of bizarre insults (i.e. prunie juice, genius, scram, idiots, etc). I actually think they do ISIS a favor. Any undecided investor can read the nonsense bashers and the coherent longs here and pick which side they want to associate with.
Free publicity for the company. People will google ISIS and the drug company will show up in the results.... some people will click and learn about it that would not otherwise.
oh well, live and learn.
You can't even type a coherent sentence. I'm trying to think you legitimately have a mental illness.
Today is that day.
Now's the time!
Would also suggest you think about GILD... $100+/share, but they are down over 5% the past two days, and have 3 FDA PDUFA dates the week of October 3-10.
All the biotechs have been down the last 48 hours, including GILD who has 3 FDA PDUFA dates coming up in October. Something is going on, but it's not specific to ISIS. Don't get spooked and make a snap decision you'll regret.
What is your point exactly? That we don't know if the entire pipleine of ISIS drugs will get FDA/EMA approval? The discount for investing in the pipeline is in exchange for the risk that the drugs don't work that well, have some long-term toxicity that's yet to be divulged, etc. Fortunately most people don't know how to interpret clinical studies so the discount is very large because most investors can't distinguish these drugs from those of any other company out there. If you want to invest in a stock where the drugs are already approved, already have years of long-term clinical safety data, and are already selling asblockbusters, you can expect what maybe 5% yearly returns if you're lucky. Cool, but for us investors who are looking for better gains, a company like ISIS has the potential to provide that for us and with one drug already FDA approved you can't say the drug doesn't work or isn't fit for human consumption...that is more speculative than anything backed up by the science.
Umm, there is an approved product already on the market. Also, yes if you're not educated in this space (pharma), it is hard for you to interpret the results of the clinical trials, but for many of us who can read, analyze, and comprehend the scientific and clinical results, there is no assumption being made.
BIO as a sector may drop due to less speculation, but there's not reason that a company with so many late state clinical candidates is just going to plummet due to an overall market correction. The only way that would happen is if there's some really bad news (toxicity or no efficacy across the entire platform). I mean honestly, even if the stock were to drop due to correction, rumors of buyout busting, etc, the long-term is still there for those who believe in the company's pipeline and can stick it out, that's the point I'm making.
But how many of those companies have a pipeline of 30+ clinical stage candidates? I would venture to say not one. If the market tanks big, we're all screwed.
Why do you say the the sector is questionable no matter how huge the pipeline is? Biotech is hot, buyouts are common, all trials keep moving forward with associated milestone payments, there's nothing to just justify being skeptical. The buyout rumors might be a bust and it'll drop again, but then you should just buy back in at the dip, because long-term there is nothing to stop a company like this from making you lots of money.
Don't sell yourself short, even if the buyout rumor is a bust (I honestly think it is right now), just look at the pipeline and active phase 3 trials... This company will be the next genetech!
Great post. I would add reason # 6:
6. Their employees know what they have and work harder than anyone I know (12-14+ hour days or 70-80 hour weeks are the norm at ISIS).
Agreed. Also having met some of the senior level people myself, I can tell you these people are not going to sell themselves short. Everyone at that company works 12+hour days regularly. They know they have the next genetech on their hands.