this is another dendreon...except its years away from becoming the next Dendreon....better still..this is the next Celgene....when it was a paltry $3.69 (based on Price/Market cap)
the results announced today are for a Lupus drug....on the high dose drug 57% of patients improved their symptoms and life.
vs. 43% placebo patients....
the placebo reading should probably tell you more about Lupus and why it hasn't had a single drug approved to treat it...it's a messed up disease for sure. ...but tough placebo hurdle to jump over....a sugar pill is far more safe.
But HGSI are the closest to becoming the first to market for that indication.
This friends is a holding for the next 10 years....IRA money.
In only a few months they should finish their second large trial and be ready for registration.
Risk here is that this larger trial doesn't show the same greatness that the first trial did.
The first trial had 865 patients....that's a pretty good sample size even for a 3 armed Clinical trial. Every arm takes away from your statistical power....this is Clinical Trial Jargon for "playing with a stacked deck is cheating a bit." In this case the deck is they have 2 arms containing their drug vs. placebo....which is why they have to recruit so much....It makes it harder to prove your drug works with too few people....
Stick with me...
Companies use this tactic to do 2 trials at once. Finding a dose is just as important to a company as finding a response. You can have a drug that works but only at high toxic doses...not good for the marketing team.
Yet you have other drugs that function very well at lower doses with lower toxicity...this is the trifecta in drug world. Low Dose, Low Toxicity, Monopoly in sight.
So these guys got it with this study. They saved a ton of money...found a dose, and got a signal....with a giant sample size...making it a realy strong signal.
The 2nd trial has enormous probability of success....and it'll be done in the Fall....That's incredible!
These patients are hungry even the Lupus Foundation of America is already cheering this on....they aren't really supposed to be cheerleading the drug companies in such a way.
Anyway....they will be first to market and if the numbers are right....they have a potential market of $1.2 billion in the US?!?
Feurstein's pieces is both a must read and a source for the math on this one...READ BEFORE PROCEEDING
This is how Celgene got started...so I think it's fairly safe
As for FDA risk.
I don't think it's a major problem. Though I do not know for sure, these are probably Special Protocol Assessments (SPA for short, gotta love PhRMA)...This is a contract that the FDA makes with companies up front...to design trials taylored to the endpoints upon which the FDA actually approves a drug.
So basically if you get your endpoint you win....FDA is bound to the contract that = you make your endpoint....they approve the drug...
We can ask for that kind of information (safety data) from investor relations.
BUY IT, SOCK IT AWAY... This and DNDN are both in the same boat....They are going 2000% higher in the next decade.....if not sooner.
Position: Going to go Long HGSI pretty soon.
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