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Misinterpretation of data
as a physician, I think the investor response to the recent data is completely a misinterpretation of data and statistics.
let's look at a few key point: there was a 62% improvement in WOMAC score at 8 weeks, and there was roughly a 10% prevalence of side effects. While this was not a Stage 3 clinical trial, let's look at some of the previously published data on medications that Cara is going head-to-head against with this drug. In 2000 there was a nice original investigation in JAMA Internal Medicine- a great peer-reviewed journal. The study by Roth et al, looked at extended release oxycodone in osteoarthritis. (Does this sound familiar? the recent data was looking at CR845 in osteoarthritis) 52% of patient originally enrolled in the study had to drop due to ineffectiveness or adverse side effects. Of those that completed the study, over 65% reported opioid side effects. Now the real kicker is that there was no statistically significant difference between the 10mg Oxycodone and placebo in pain intensity, mood, sleep, and enjoyment of life. Only the 20mg dose had a statistically significant improvement.
So, the data from Cara, honestly, looks more promising than the opioid dose in high dose PERCOCET (minus the Tylenol portion)! Again, I really think too many investor "scientists" that are not familiar with published data on pain management overreacted in the last 24 hours.
The markets are interesting. I like to play biotch IPOs because of my background in clinical medicine and research. I can tell you that there is a gambling component to these things. Technology that shows loads of promise often doesnt do as well initially as the tech company that is pursuing a bad technology but markets it through media outlets well.
A good example is Epizyme (EPZM). it is technology based on DNA methylation/acetylation. It is meant to silence certain genes or turn them on. This technology has been studied quite a bit. And it has continuously proved to be not tremendously effective with our current level of understanding. Same goes for some of these technologies where we try to put "good" DNA into people by means of adenovirus. It has been proved time and time again that it does not work all that great. Epizyme is trying to make tech that is further from proven effectiveness than CR845, has a smaller niche market than CR845, and doesn't have nearly the basic science foundation of CR845. Epizyme has a market cap that is 3x cara right now. And that is after a HUGE (-60%) drop over the last year.
If there is one rule of the market, it is that good things do well in the long run. And CARA has one of those good things that will probably do better than we can imagine. It's possible that it'll get approval for weird things when patent age matures. It may get a restless leg syndrome approval or complex regional pain syndrome or fibromyalgia. It really has tremendous potential. And best of all, it is very close to FDA approval.
FDA approval within reach
The threshold for approval of CR845 is probably a lot lower than most believe. Because of the tremendous safety and addiction profile of the drug, it could have the pain reduction efficacy of gabapentin or lyrica and easily get FDA approval. Previous studies have blown those comparisons out of the water, so a decent phase III trial will nearly guarantee this thing going to market.
CARA's PR team isn't too great about spreading the word about Cara. It's hard to find mention of it on pain management forums and it is one of the bottom links using a google search for "cara". Maybe a pr push sometime between now and mid-point of phase 3 trials could get some momentum before a possible FDA approval.
Pain drug to set new class
CARA Therapeutics has been developing a new opiate drug for pain management. Theoretically, the drug should treat pain without the normal side effects of opiates: addiction, constipation, respiratory depression.
They just finished a recent study that showed an addiction profile that would put it as a class V narcotic, meaning very little addiction potential. This could be the start to a new realm of pain management. Not just post-surgical pain, but also chronic pain.
CARA news release
Gregwit, I'd say it's a very good buy under $10. Unfortunately, it will be a year or two before there is the potential for HUGE upside.
There has been a growing movement in medicine to limit opioid medicines. The recent resurgence of heroin mixed with fentanyl only added to the fears. Even the low level opioid drugs are being reclassified as higher level narcotics. There are countless people addicted to norco, percocet, lortab, etc. Now the mechanism that makes opioids dangerous is the activation of mu-receptors in the central nervous system. This leads to the addiction. The lead candidate for CARA is an opiate. However, it acts on kappa-receptors, and it cannot enter the central nervous system.
Initial studies showed that the drug worked to reduce pain. And in those that didn't have pain adequately controlled, the amount of morphine required was reduced significantly. So the potential for addiction, the reason why opiates are becoming more and more controlled, is much much less with CARA's lead candidate. Their lead candidate also doesn't affect the gut like traditional opiates, meaning there wont be the constipation.
All of this means CARA's lead drug candidate could be a major pillar of pain management. Right now looks like the initial indication will be post-operative pain. But the oral formulation could move into the chronic pain realm. The most profitable medical fields are ophthalmology and pain management. If CARA gets FDA approval, which seems extra likely because it doesnt have the dangers of traditional opiates, it will be massive. I mean billions. Not a market cap of one or two billion. I mean yearly revenue of billions.
So, definitely keep an eye on CARA. But don't look for any homerun days until Stage 3 clinical trials are at least 3-6 months into investigation. If the data looks good in the beginning, the clinical trial could be cut short and it could be submitted to the FDA before the target date. I think this is the kind of company that you should only invest in if you are young. It is risky, but the reward could be huge. And you wont see profits overnight. This is one that requires some maturation. The earliest that I see this being able to skyrocket is mid-2015. The latest, 2017. So if you already have an emergency fund, 401k maxed, debts paid, and maxed IRA contributions this year, I would definitely jump on CARA and wait it out.
CARA is definitely going to take a bite out of $6B post-surgical pain management, according to CEO. this one is getting prepped for an impressive run.
i think it's pretty easy to know when to get into this stock. the fact is, opioids are how we treat pain. if you have pancreatitis, sickle cell crisis, or just had cardiothoracic surgery... you get opioid pain meds. no amount of cannabinoids will treat the pain involved in extreme medical crises. if their lead drug makes it to market, it will revolutionize pain management. As in, multi-billion market. do you have any idea how many people take lortabs and percocets? all of those will be gone. even if this company has poor phase III results, which still maintains the risk vs benefit argument for traditional opioids, it'll keep growing until the end of 2014.
if you're looking to double your money overnight, this company isn't for you. If you're looking to double it over 6 months, this might be a good option for you.
Translation to all fields of medicine
biologic therapies are already huge money makers. they are used in certain breast cancers, rheumatoid arthritis, ankylosing spondylitis, crohn's disease, certain lymphomas, etc. Imagine improving each of the current therapies for all of these conditions. at the very least, Xencor Inc could lease engineered Fc-fragment patents to each of these companies to improve their current therapy.
i see XNCR reaching ~$13-16 before any results are published. and depending on the results of current trials, this company could be worth billions.
i think it's already picked up too much steam, Kaiser. it isnt going back down for a while.
i think it all depends on the first few hours tomorrow. if there is a hesitation to go in to the ~$0.20-realm before noon, the loyal few will jump ship.
ive never seen such negative manipulation before with an APS pick. APS usually has it on lock. i'm really not sure how to interpret it.
you mean highly dumped.
everytime the price got around $0.40 there was a a big selloff. usually APS makes sure the promoted company doesnt give in so early. this hasnt really moved like any other APS play. if XUII were to break $0.45, it will grow +5-15% daily until $1 then slow down a bit. and then it'll absolutely start to look like the APS plays that we're all used to.
data isnt what makes something biased. it is the source. when pharmaceutical companies fund a scientist to test their new drug and the results seem good, everyone turns their head and questions the validity of the experiment because there was a vested interest. even if the data seems reasonable, you take info from a biased source with a big grain of salt.
are you talking about the Seeking Alpha article written by the friend of the guy suing APS and other promotion entities?
that seeking alpha article was written by one of George Sharp's friends. he even states that he has exchanged many emails with the guy. i'm not sure you can find a more biased article on the whole internet.