I don’t think it’s any secret the Small Cap Network is an opinionated source of stock-related information. That’s by design - you can get ‘data’ anywhere, but meaningful opinions still seem to be a rarity.
It’s a point I wanted to stress today before I shared my personal take on some recent news from CEL-SCI Corporation (AMEX: CVM). They provided the facts; I’m just providing my opinion on what it ultimately means. In this case, I think the news may be a proverbial grand slam for the company. Whether you’re a full-blown CVM owner, or just mulling it over from a distance, trust me - you’ll want to keep reading.
First things first though, particularly if you’re new to the company.
Though it’s not the only drug CEL-SCI is working on, their primary focus has been on the development of a drug called Multikine as a treatment for head and neck cancer. Though Multikine is still being evaluated through the required FDA procedures, early testing indicates it’s very effective. In fact, the research so far shows a 33% improvement in survival of patients using the experimental treatment (which is quite a bit by medical standards). There’s really nothing else quite like it that’s tumor-specific in addition to being non-toxic.
OK - now with everybody on the same page….
Over the past few months, from my perspective, CEL-SCI has gone from being a question mark to being an exclamation point. You may recall in November we posted a blog entry asking our readers to write to the FDA and urge them to allow Multikine to proceed into Phase III testing (the final stage of the FDA approval process). At the time, the company had been waiting 22 months to hear from the FDA, with no explanation for the delay. Needless to say, everyone - the company, investors, even patients - was getting frustrated. It didn’t bode well for Multikine’s future.
Then on January 16th, things changed for the better - CEL-SCI got the greenlight from the FDA to take Multikine into the next stage of testing.
Though Phase III is obviously still not a final approval, we learned something after the news came out that we didn’t know before….approximately 2/3 of the drugs making it to Phase III testing are ultimately awarded FDA approval. I felt this was an outstanding sign of Multikine’s chances, especially considering Phase III was pretty much a large-scale version of Phase II, and was likely to yield the same results.
Well, I thought the story was pretty good as it was. I believe today’s news made it even better though…..far more encouraging than I ever imagined.
Multikine’s use as a head and neck cancer treatment has been designated as an ‘orphan drug’ by the FDA. What does it mean? The ‘orphan’ status is a good thing. To encourage the development of drug treatments for diseases that are very rare, the FDA sweetens the pot, so to speak.
Why would they do this? Let’s face it - big pharmaceutical companies are more interested in targeting common diseases and illnesses. If there’s not enough of a potential customer base for a treatment, it just doesn’t get developed. Needless to say, that’s far from fair for those affected with uncommon illnesses.
As you may have guessed by now, head and neck cancer is considered a rare disease by the FDA. It’s estimated there are 500,000 (or more) new cases of head and neck cancer every year. Perhaps by GlaxoSmithKline (NYSE: GSK) standards that’s not a lot, but here’s where the power of being small is huge…….relative to CEL-SCI’s size, 500,000 potential patients each year is a massive number - plenty big enough to encourage them to develop a drug like Multikine. It may be a billion dollar opportunity, which is enormous for CEL-SCI.
Here are the main benefits of having an orphan-drug status:
1) Seven years or exclusive marketing rights after the drug is approved (regardless of the patent’s expiration)
2) Potentially, a faster approval time from the FDA
3) Potential grant money - up to $350,000 per year for three years, in CEL-SCI’s case
4) Tax breaks - up to 50% of the R&D costs
Now, I haven’t told you anything you can’t read (or infer) in the press release for yourself - yet. Here’s my perspective…..
There is one thing that strikes me about Multikine being granted this orphan status. Is it me, or is the FDA rolling out the red carpet for Multikine (to the largest degree that they can anyway)? I recall the company using the term ‘fast-track’ a few months ago to describe something they were hoping for Multikine to benefit from. I don’t know if this is what they were talking about or not, though I suspect it is. I do recall that the FDA fast-tracked drugs when they were desperately needed, and there were no alternatives quite as viable as the one in question.
The way I read between the lines, this makes the odds of Multikine getting final FDA approval even better - and they weren’t bad to begin with. Yeah, there’s always ‘a chance’ of something in the meantime, but the FDA is now doing what it can to support Multikine’s progress. Seems to me that’s a big deal. Yes, I see it as yet one more reason to own CEL-SCI. The dream seems to be making big progress towards becoming a reality.
Click here for the press release.