As all of you know, recently, watching CLDX trading it is like watching grass grows...However, good things on horizon, and looking at thee big picture, IMO, the following should happen:
1. FDA ok to submit NDA - 1 month.
2. NDA submission (for refractory)- 2 months.
3. Approval - 4 months (i.e. beginning of 2016). At this point I expect CLDX trading at $45.
(I do not mention here possibility of p3 interim results, since AM said it is very unlikely that they will be so good that trial will be stopped. So, if it does happen it will be pleasant surprise)
Now, in long run lets see what CLDX worth. Bio's valuation usually is not based on P/E and I don't like "discounted future value" models,- no, I usually use much simplistic approach- 3 times peak sales.
So, two leading candidates should produce peak sales about 1.5B, so just them will justify $45-$50.
Now, we have Varli, that true potential (sales) is really unknown....But ,if we assume another 2B, we can expect CLDX to trade at $100-$110 in the next 4-5 years, if not bought out before. So, maybe this seems like long time to wait, but 4 years ago CLDX was trading at $3-$6? So, patient investors who waited, quadrupled their money. And, IMO, there are good chances it will happen again!
Sentiment: Strong Buy
MBB, they clearly can submit NDA for ReAct, not newly diagnosted and my understanding they're planning to do so. While the target population won't be large, but approval will add legitimacy to CLDX platform, enable off-label use and propel s/p to new highs.
MBB, OS benefit was statistically significant and, taking into account the absence of serious side effects, it is sure bet that it will be approved.
If nothing happens in July, then it will be CC in the August, so we'll have chance to learn about new developments.
What is more interesting is how high are the chances that second interim analysis (75% events) will produce statistically significant results so the trial will be stopped for effacy?
AM has said that first one- don't expect it, but he did not mention anything about second one....
There is no "pumping" here, just mere speculation to what will happen in the conservative/best case scenario.
So far CLDX did not have single trial failure so there is a reason to believe that current trials won't fail. You, of course is entitle to your own opinions...And, while my expectations of success of IMCL, MLNM, MEDX, OSIP, MACK, ONXX and few others made me a lot of money I was wrong in case of SVNT & AMRN (so far). So, I bet on fundamentals, i.e science and you - on trading algorithm only. So, I've about 37 years of trading experience (including few years as day trader) and I can safely predict- you're not going to make money shorting CLDX in long term.
Dorris, would you please share with us your exit strategy with CLDX? What is your stop-loss (if you have one) point and how much you're going to lose if CLDX indeed hits $45 in 6 months?
I also would like to know why have you decided to short CLDX? There are a lot of more controversial bios (JUNO for example) that shorting them is-"high risk-high reward" strategy, but CLDX?
Dorris, I'm really curious, what is your trading strategy for CLDX? At what point you're going to close position andwhat is your stop-loss?
So, if I understood you correctly, you're going to hold short position in CLDX thru binary event? Well, we all would be glad you do!
(And regarding JUNO- dig dipper- the OS & PPS and side effects are not that good. No position, btw, this was just an example)
The reason for not having any partnership (besides Varli) is that
Rindo & Glemba are relatively "small potatos" for large bio and not necessary bad thing about product by it-self. However, you can bet that the moment Varli shows wide range of possible applications, CLDX will partner it or, rather, will be bought out.
It takes time to get results. So, CLDX time will come and maybe sooner than you think. We'll talk then...
I expect us to get to $40's in 1 year. And $80 in 3. Don't think $50 in less than 1 year.
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.
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.
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....
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.
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...