BLRX has partners. CTIX doesn't. I added BLRX. I have not added CTIX. What happens to CTIX if B fails phase 3? Remember, we have a monkey (Leo) running the show here and I would not be surprised if Leo pushed B into phase 3 when the data in phase 2 didn't warrant taking such a risk. When little pharma's who don't have institutional shareholder investor base and no large company partners make a decision to bet the company on a phase 3, it sometimes makes an over-risky move. See what happened to CTIC over the years with one failed drug after another. See also XOMA. But BLRX had licensed this product 6 years ago and did not make the risky move to develop a pioneering drug. Look at the rest of the BLRX pipeline and the partnership with Novartis. There's much more upside in BLRX than CTIX, the reason why I added. Remember how the West was won, pioneers got arrows and settlers got land.
The Farber paying for clinical trials? Are you smoking something currently legal in only 3 states? As for the FDA granting QIDP and orphan indication status, why don't you check the standards for those designations. It more than a quantum leap to K approval since orphan indication status for a drug has a very low bar for efficacy, such as in vitro data (lower than an IND). Given K's lack of toxicity in it's dose-escalation phase 1 safety trial, one should be questioning a lack of efficacy as well. The value here is all in B. The other two drugs are far too early in the value curve because they are very risky and risk is inverse to value.
George writes: "Some posters on this board want your t believe that for psoriasis treatment reducing TNF alpha is the best approach," Huh? Have you read what I posted George? I am no fan of TNF antagonists for treating a dermatological conditions. Not only is there a cost/benefit problem, there is an efficacy/safety problem in view of the terrible side effects of TNF antagonists. But George, your "new research" is preclinical and may or may not be predictive of clinical effect. This is why the risk of P is very high. And risk is inverse to value, so I assign little, if any, weight to the P asset in valuing CTIX. In fact, I attribute very little value to K. But I think the bulk of the value is with B. As for K and the cancer market, I think you guys need to look at what is going on with some of the cellular therapies in clinical development. K is old school and I think biologics with cellular therapies will become the bulk of 21st century cancer treatment. This is my opinion and I'm putting my money where my mouth is (in terms of what I invest in). For me, CTIX is one of my anti-infective investments, the one that hasn't taken off yet like the others have. I consider K and P to be noise.
You're a bit confused on the science side Peter. All of these drugs are TNF antagonists. Embrel doesn't block the TNF receptor, it is a fragment of the TNF receptor (the extra-cellular domain fragment). All of the TNF antagonists act by binding up and removing the ligand TNF, either by using the receptor extracellular domain (Embrel) or by adding a human antibody (Humira) or a humanized antibody (Remecade). But what concerns me is the common side effects of soaking up ligand TNF are pretty severe (infections and cancer). TNF stands for tumour necrosis factor and it plays an important regulatory role in directing a body's immune response, hence the side effects of infection and cancer by over-limiting the immune surveillance role. And by the way Lee, where did I learn this stuff, yup, Penn. So respect the old red and blue. And understand your market segments. And better yet, diversify as there is a significant market correlation among company stocks in the general category of biotechs. I've been selling the leaders (CEMP, ZIOP) as over-valued and buying/holding the laggards (CTIX, SRNE and BLRX) all with market caps under $1Bil. But CTIX still has very weak management compared to its alleged peers.
Check SRNE lee. Better move than CTIX and this past week was the best one for CTIX since I've owned it. There's much more to the universe than CTIX.
Made about double that yesterday, on paper. Since I'm more diversified, the big gains in CTIX, ZGNX AND the Big Kahuna SRNE caused it. But it doesn't matter because you have to sell it to take your profit. Didn't sell any of the aforementioned 3 stocks as I think all 3 have not hit their near-term peaks yet. But I did just sell CEMP and took a profit. With my luck, it will put on the after-burners next week.
No George, there's lots of competition in the psoriasis market segment. Managed care clinics will start with the cheapest approved treatment and progress up the scale of costs. That means one starts with generic methotrexate (after topical creams) that costs about $1K per year. If that doesn't work, there is a "middle market segment" that Pruisol will be addressing that also includes Otezla (when will it go generic because that will determine pricing power of Prurisol in the middle segment), and another drug I've been developing that can compete on price with methotrexate and go for about $3K per year (remember Otezla is about $13K per year). In other words, there will be significant price compeition in the psoriasis middle segment.
If those fail, it means a TNF inhibitor biologic is the last resort. The TNF antagonists biologics are very expensive and include Embrel, Humara and Remicade. My sister-in-law (with another autoimmune condition) was on a TNF inhibitor biologic and was just diagnosed with a lymphoma. Unfortunately, blood-related cancers (leukemias and lymphomas) are an unfortunate side effect of TNF antagonists. That is the worst possible side effect for her, a breast cancer survivor.
I'm also long THLD but it has not moved much. Has much better management than CTIX but not as many drugs/assets. Has much better access to capital. Has anyone been watching my SRNE recently? Have a big stake in that one. All I can say is CHA CHING!
Learn your pharmacology. Not seeing side effects in a phase 1 trial means there is a higher probability of not seeing efficacy as well. One wants to see what is known as a therapeutic window when developing drugs. The only alleged efficacy with B has been some rat studies, not generally a good predictive model. Or this could be a pharmacokinetic problem where the drug is being metabolized too quickly and not getting to the site of action, that is a possible reason for the phase 1 results. It also means no efficacy.
Orphan designation is an easy process that has a low standard of review and published evidence. Product approval (orphan indication or otherwise) is an entirely different ballgame. It's easy to obtain orphan designation, all one has to do is show (with published evidence) that the number of patients in the US is less than 200K. But one cannot piggy-back off other orphan designation files. Product approval requires controlled clinical trials showing safety and efficacy, and there are ways to utilize files or earlier drug approvals (this is the advanced course when one gets to ANDA's and 505(b)(2) applications). And yes I work in the industry, like Franz used to, but I have more of a regulatory function (Franz was sales).
baytdr, You're confusing orphan designation with approval for marketing. Any drug needs to establish safety and efficacy for approval. An orphan indication means less than 200K patients n the US. The benefits of an orphan indication are a longer term of exclusivity for a new compound (7 years versus 5 years) under Hatch Waxman. But an orphan designation does not change the requirement to conduct controlled clinical trials to prove safety and efficacy. As we've read, the phase 1 trial has shown safety pretty well but is worrisome in not establishing a maximum tolerated dose. Generally you want to see side effects so you know what to look for in the later stage clinical trials. I bought this stock (long) just over a year ago due to the anti-infective, but I don't ascribe much value to K at this point. And todays news does change that valuation thinking.
Wrong!. This was not drug approval for an orphan indication. It was only a designation that ovarian cancer is an orphan indication. Safety and efficacy still have to be proven in clinical trials. The phase 1 trial showed safety but did not establish efficacy. Nothing has been "validated" whatever that means. There's nothing new in this press release, only a showing of gullible investors.
You'd better go back and read what happened. Nothing was "approved." Ovarian CA is an orphan indication. If a clinical trial is run in ovanian cancers, it is an orphan indication. Any pop today only shows that the investor base here is unsophisticated retail, not institutional. That's it.
"Significant press release?" There haven't been any significant press releases yet. I actually like that Leo finally learned to keep his yap shut rather than opening his mouth and sticking his foot in it yet again. We need more institutional shareholders and less like esque. So go ahead and sell esque. I may finally add to my 25K share position in the event that Leo's blissful silence means CTIX is actually accomplishing something and moving the ball forward with clinical trials.
Like the game tonight in hot and steamy Van, just up the road. Hope this miserable heat wave finally breaks. My UVA grad daughter was there. Peach Arch is going to be a zoo in an hour or so.
Herbie, Do you still have reading comprehension issues? Do you understand the difference between the past tense and the present tense? Apparently not. I don't need to repeat myself, it's written clearly above. But I love making money (for myself) when the uber-hypsters like Herbie post meaningless drivel in efforts to pump up a stock price, so I can short it again (like that wonderful run to 4+ on nothing substantive). So keep on name-dropping Herbie. It means nothing. Where people worked (did you know Herbie, Illumina was given this entire week off?) is irrelevant. If Ms. Thomas wants to do some Board work to pump her resume, good for her. That means nothing for the scam hype TBIO. Go to real sources of information, like the medical literature and patents. There, name dropping means nothing. Data talks, hype is a waste of bytes. So please Herbie, do another pump to 4+ so I can pay more taxes this year and help out the federal budget.
No I'm going for a long term cap gain in TROV. And by substance I mean product assets. That is what one measures with development stage companies, not revenue and profit type metrics. Rea the medical literature, read the scientific literature and read the published patent applications. By going to the original source material, not the musings of pundits and wags with an agenda, you'll see unvarnished information that you can use to make your own decisions. My positions are based entirely on my research and you should all due your own due diligence and not rely on the pundits and wags, or what I did. Remember, the first post on this thread asked for what folks can do together and my contribution is to suggest that each person ignore those with a agenda (like the PR folks who post the hype) and go to better and unbiased information sources, such as medical literature and patents.
Perhaps what you could do is some due diligence. What assets does TBIO have? In my opinion and according to my due diligence, there are no assets. Yes you should compare TBIO to TROV and see what is the difference, like products supported with published (peer-reviewed) scientific and medical journal articles. Get away from the puffery and male bovine excrement of press releases and look at substance. You'll see why I'm long TROV and I was formerly short (since covered at a significant profit) TBIO.