Your feelings are shared by a lot of frustrated longs...However, we should keep an eyes on the ball and remember about a big picture. I'm sure that management also would like to announce something positive, but apparently, things take time and who knows why discussions with FDA are taking that long? After all dealing with burecracy is never fast. We probably'll get some update on CC in 1-2 weeks. And, in any case there much more coming,- Glemba, Varli etc, so patience is a virtue and long time investors will be rewarded.
How high is probability that p3 will be stopped for efficacy on the next reading (expected year-end)?
And, unrelated question: your opinion about KPTI?
It is very hard to put a price tag on bio without revenue and with a lot of drugs in development without any real idea when and if they'll be approved and what is the market potential.
However, KPTI has very strong fundamentals, i.e. no trial failure so far, "deep bench", i.e a lot of promising candidates and looking on similar bios, I'd say that KPTI is currently undervalued and even without any additional positive news should be worth at least 1.5B. In long term, with some positive developments, it will worth much more, and if shareholders will execise some patience, they will be rewarded.
Whip & Ray, this was the case until few quarters ago...I think last year, after hiring PR person it was decided that CC serve also as an instrument to increase awareness of CLDX and provide "moral support" to shareholders, and, therefore, now CC's are conducted regardless of presence of "real news". However, it does not mean that it will be no new news, and, on the top of it, this is an opportunity for the analysts to ask questions that are of interest to all of us....
I, personally, hope that time frame for new expected catalyst will be announced (Glemba, Varli, trials etc, and of course Rindo), and the most interesting (and important question) if there are expectations that on the next read the DMB will stop the trial for efficacy?)
1. I don't remember now info about improvement in OS compare to SOT, but these number are easily traceable from p2.
2. Regarding 400-500m, - this one is easy: at some point AM said that they will charge on par with similar treatments, i.e. about 100k-120k a year. It is estimated that out of 43k-46k people with brain cancer about 4k-5k are the patients that can benefit from Rintega so here is how I came with 400k-500k peak sales not counting outside US.
3. I estimate CLDX s/p at $50 based upon 5 times peak sales+the rest of pipeline.
4. I also disagree with statement that BP will buy only when results are proven,- while lately I observe that tendency, I can give you few examples MEDX, MLNM - were purchased before getting to market. And, the latest buyout for 7.2B also good example...
Myown, Glemba is one of the unknown in CLDX valuation and we can just guess is slow enrollment the only reason. However, what we do know that so far CLDX's drugs were able to produce if not spectacular, but very solid results that should be enough for approval. All of this is just matter of time and approval of Rintega will bring us to $40+
Rulebraker, I disagree with you regarding market potential: while median improvement could be 2.5m for some patients it is much more. On the top of it, these 100k is paid by insurance and taking into account excellent side effect profile, I've no doubt that Rintega will get to sales of 400-500m at some point.
And, if we're talking about valuation- Glemba+Varli has quite large potential and I expect in 2-3 years CLDX to trade at least $55-$75.
Myown, the market does not value bios by level of expenses, but rather by chances of approval and size of the (potential) market. BP (big pharma) is always on lookout to expand their drug portfolios and since their buying power is enormous and additional costs are marginal (since the distribution channels already in place) they worry about only one thing: the size of potential market (this is BTW, why PFE few years ago walked away- they've decided that potential market of 400-500M is not big enough for them). So, at this point the only one thing that holding us back is timing of approval and p3. Approx in 2 weeks we'll have quarterly CC and I expect some announcement BEFORE (this is what CLDX management usually doing- they release some news few days before CC and then repeat it again. So, as it is with most of the bios - patience is a virtue and will be rewarded....
While I do believe in the bright future of CLDX, at this point there is a lot of uncertainty - when they submit for approval, how p3 will turn out- will it be stopped at the next reading, what is with Glemba and when we'll learn how it is going, what will be results with Varli, etc. And, while until now the fundamentals, i.e. science was always CLDX strong side- (no single trial failure!) we're now at pivotal point where CLDX need to show results that not only good from scientific point of view, but lead to approval. So far it is not happening (FDA stalling, trials take time etc) and we are trading in "trading range". So, my point very simple: when we get fundamental news we'll move to new level, this is just matter of time.
Whip, while I do believe in the bright future of CLDX, at this point there is a lot of uncertainty - when they submit for approval, how p3 will turn out- will it be stopped at the next reading, what is with Glemba and when we'll learn how it is going, what will be results with Varli, etc. And, while until now the fundamentals, i.e. science was always CLDX strong side- (no single trial failure!) we're now at pivotal point where CLDX need to show results that not only good from scientific point of view, but lead to approval. So far it is not happening (FDA stalling, trials take time etc) and we are trading in "trading range". So, my point very simple: when we get fundamental news we'll move to new level, this is just matter of time.
Whip, while I'd be glad to see $200, but with expected peak sales of just 1.5B , $75 will give CLDX 5X expected peak sales. I realize that Varli MIGHT produce great results and will be worth another $2B-4B, but I doubt it will happen that soon.
Chris, ONXX had 1 drug with annual sales about 1B and another one coming with similar potential.
From the point of view BP is less risky to pay for sure thing than to pay less, but for "potential". So, do not expect buyout offer until we get Rindo & Glemba approved. Then we should expect about $75-$80.
Frank, there are so many gulliable Democrats around that any thing he does is goes like "Torah from Sinai"(Israeli expression). the only hope is that Republican will be able to master enough votes to stop it.
Usually, I'm trying to avoid political posts on this forum, but on this particular occasion...With our current president, attempting to please all our enemies, not understanding single thing about way of thinking these terrorists and totally anti-Israel, we need just to hope that he won't more damage in remaining time and that new president whoever it will be, won't be Hillary, because all her talents are in manipulating people...
Carlrich, while I'm also was/is expecting NDA soon, something holding it back...Probably during next CC we'll learn what is going on. True, if it is submitted before end of August we might get approval before EOY.
By the end of '15 another interim analysis is expected of P3 and my understanding this is reasonable probability that DMB will stop trial for efficacy. In that case approval of refractory will be moot compare to expected approval of first line- probably in the mid-2016
BTW, I expect that s/p will move to $35 by EOY in expectation of DMB and if positive we-ll get another 10 points. If not, then back to $25....
The Big Pharma, rather pay more but for sure thing than pay less but for "potential" (ONXX was good example for it). So, if we're talking about buyout, it might happen only after Glemba approved or Varli shows tremendous results and I think, then will be around $75.
I wonder if you ever read quarterly CC or any publications brought up by Long...or just look at chart...One day you're going to lose a lot of money on CLDX.
I also disagree with "success rate is so small", I actually think that it is relatively high....Would you mind share with us your cost basis?
However, I do not expect any real news announcement tomorrow- these conferences are improving awareness of company, not for status update. The only news, maybe, we'll get is regarding negotiations with FDA and I'd not bet on it,- in 4 weeks we'll get quarterly CC, then, probably (if not before) we'll have a chance to learn about any regulatory advances.
I expect us to get to $40's in 1 year. And $80 in 3. Don't think $50 in less than 1 year.