I can also speculate that if it were some bad news, AM would try in person sugar coating it....
While I'm less sure that management will try to get FDA approval for Avastin refractory patients simply because AM usually takes more secured even more lenghty path to approval, I also think that Rindo will show statistically significant improvement in PFS, but while it will be improvement in OS, it probably won't be statistical one.
I also think that even if we see somewhat positive results the s/p will go down up to 15%, but will recover by quarterly CC or SNO.
Of course if we see OS & PFS statistically significant we'll see $20+ or even $30+.
I'm leaving today for Maynmar, no internet most of the time, come back on 11/20 and will see what actually happened.
I also don't believe that we'll see $9. The worst case scenario is $13. (This believe based on fact this forum is more fit to report at least somewhat positive developments and not outright failure.
It is also possible that while patients were relapsed & refractory Avastin, the combination with Rindo very well could produce better effect then each one of them separately....)
Whip, from what I learned with ARWR the abstract will provide full details with numbers.
And, I expect "sell on the news" reaction from all short-term traders. However, it is possible that before the presentation day, CLDX will have quarterly CC where more positive light will be put on the numbers (in case they're "mixed bag").
My understanding that we're dealing here with population that in worse condition than p3, so it is very well possible we'll get worse outcome for them then in p2.
It does not change my long term outlook and expectations ($45-$65 in 1-1.5 year)
Whip, CLDX needs to report RR for at least 5 people and OS for about the same. If we get better results (or worse) s/p will react accordingly.
If you want to get an idea of abstract importance look at ARWR recently....
Bingoo, what was CLDX market value 10 years ago? what was your target sale price? What binary event you targeted as decision point?
We've advanced in 10 years, maybe not that fast as you and me (and a lot of others) hoped for, but still...now, we have clear time table to actual results and, therefore, to serious price appreciation. There is no point in looking on day to day price changes- why we went to 12 and back to 18 and back to 12? Our reward will come when Rindo approved, Glemba approved and Varli reports very good results. Until then s/p totally depend on anectodic updates and investor's mood swing...
Zorb, if initial response rate of 15% is touted as "good result" then there is no reason to believe we'll see "bad results" now. OS is totally different animal and I expect them to report positive OS results, but, probably not statistically significant (this is conservative approach; I've no clue what actually will be reported, of course). What will happen to p/s in this case?
IMO it depends on price action going into 11/3: if we see $18+, then "sell on the news" mentality will bring it back to $13-$14 TEMPORARILY.
BUT: somewhere between 11/3 & 11/114 CLDX will report quarterly results and this will serve as opportunity for AM to calm down naysayers and, hopefully, report some progress in Varli (where the real money is) and Glemba.
I realize the difficulty in making decision for the short-term traders, but here we're talking about fundamentally sound bio with potential to be $45-$65 stock in 2 years. Also the lower the current expectations are the better chances to see $30+ in 2-3 weeks.
So, in short, I think investment in CLDX requires time commitment of at least 1+ year,- if for example you're starting business, you'd not expect it to make money immediately, but rather give it a chance to "mature" (get recognition from customers, referrals, etc). The same here-patience required!
Whip, " if we were to meet this significance -- we would have to see a fairly significant difference"-
My take: AM basically hints that we should not expect too much (i.e. statistical significance) from that particular group in OS, but rather respectful response rate. So the news are going to be mixed bag with, hopefully, positive spin put on it in presentation.
However, in general until now it was no single scientific failure so far and while results never were too spectacular, they still were very solid and there is no reason to believe that p3 in Rindo will be any different.
So, p/s can move 10%-25% in any direction after abstract publication (or presentation), but in the long run I do believe we'll get positive results from interium analysis of Rindo and, high probability of approval.
The real money though, are in Glemba, and the moment we'll get some positive updates here the move similar to Puma is in card. I'm holding very large position in CLDX and while current p/s is disappointing, the long term picture is much brighter....even if current abstract come short of satisfying short-term traders.
Whip, it was wonderful answer, the only problem I'm having with it, that all your numbers you're quoting are from the people trying Rindo as 3+ line of therapy not the first one, as in current trial...
1.I'm sure Tom Davis is aware about enrollment timing and still he him-self mentioned "slower death rate", saying they're investigating it.
2. 50% of death is about 350- not much difference with 374.
However, I was under impression that patients randomized 2:1 - (I probably mixed it with CDX-110 trial). In that case reaching 350 death requires basically just most of control group death.
Still, since the trial conducted as first line on patients with stronger immune system, isn't historically expected OS for control group is higher than a year 1? (From IMUC trial I vague remember that in their control group 60% were still alive after 12 months. I could be wrong...)
1.Since we all expect Rindo to work, then this could only mean that control group living longer, and, while as a person, I don't wish on anyone to die faster, as investor it makes me worried - it will be harder for Rindo to prove statistically significant advantage in OS for Rindo
2. In CC it was said that 374 events (i.e. death) "expect to occur in H12015". Since the trial has only 233 patients in control arm, we can get these 374 "events" only if most of them die AND about 1/3 of Rindo patients die too. BUT, if rindo really work as in pII, then its patients supposed to survive longer!
In short, it seems to me that we're not going to have these 374 events in the 1H15, but rather later and this is rather good thing!
I'd like to hear any opinions or any other possible explanations, if anyone things I'm missing something....
Lv, could it be that events happening at slower rate because placebo arm lives longer?
And regarding groups 1 & 2C, in my view they did not sound that optimistic...
Cramer might affect s/p short term. No question. However, at the long run the fundamentals always win! And eventual approval will bring s/p $40-$50. So, the patience pays!
I do not expect CLDX to sign new closed end partnership with BP, because usually in this sort of deals, small bio get:
1. Upfront payment;
2. All development expenses paid by BP
3. All marketing paid by BP
4. ....But...only about 15% royalties on future sales
This type of deal is good for company with market cap of up to $100-$150m- it allows it to establish name for it -self and make it possible to concentrate on science and not on finance. However, if success achieved - not much in terms of money coming its way. On the other side, BP interested only in potential blockbuster drugs, i.e .with expected sales $3B+ (BTW, this is the reason why PFE went out of deal with CLDX)
CLDX size company with money from the recent secondary does not need this type of deal. It still might sign some collaboration agreement similar with BMY (and this type of agreement frequently lead to buy-out. For example GSK bought out HGSI when the split was 50-50), but thiss type of partnership does not affect share price much.
So, for now, everybody unhappy about s/p (including me) need to sit on his hands, patiently waiting for trial results, FDA submissions etc. One must realize that if CLDX would be trading in $20's and expected unloading of shares happens at $45-$50, it still would not make any difference, just moral satisfaction that "we are closer to the target price" but not more than that.
Of course if you're trading in and out of position it is different, but for long term investors it would be the same.
Sentiment: Strong Buy
Dorris, at $40-$50 CLDX valuation will be 3.6B-4.5B which in my view for company with approved pick sales products in 1.5B area is fair. Theoretically speaking if Varli shows great-great potential (lets say 3b sales), then we can talk about CLDX selling higher than $40-$50. But this is matter of more than 2 years....
Mybest, the fact that the price now is much lower than year before is just a temporary lag between fundamentals & the s/p.
And when grey saying that we're in much better position now it means our fundamental are much better and we're closer to approval than before. And price always follow fundamentals!
So, this is a matter of time when we see valuation of 4-5B and Id bee much more worried (and probably out of position) if we'd be trading at 30+ but got bad trial results!
Gofo, I don't think we're going to get anything really important (for example trial results are important)....Just general update about enrollment, self-promoting rah-rah and how great we are. The real results will come in November, then I expect substantial price increase, may be like last year to $31.
Mja, mid 40's would be 4B valuation...At this point it would be really good. (And, BWT, PBYI went to 240 at one point- i.e. 300%. Similar move would bring CLDX to $52. If that happens -I'm selling)