The company has stated that an interim analysis of the registrational trial for CDX-011 will be conducted after the enrollment of the first 80 out of 300 total patients. If the results in the triple-negative, high-expressing GPNMB patients are similar to what occurred in the phase-2b EMERGE trial, the early stop of the trial for statistically significant demonstration of efficacy should have a very high probability. I mean, come on: the p-value for PFS in that population in the EMERGE trial was p=0.008, and those were heavily pre-treated patients.
CDX-011 is the kind of horse you bet on to WIN because it is so superior to anything else on the race track.
We might be looking at early stops for both Rindo and CDX-011 for demonstrating efficacy, and perhaps FDA approval of each in 2014.
This is not the time to sell. THIS IS THE TIME TO BUY AND HOLD.
From Celldex's website:
Celldex will evaluate CDX-011 in patients with GPNMB over-expressing triple negative breast cancer in an accelerated approval registration study at approximately 75 to 100 academic and community centers across North America. This study is expected to begin enrollment by the end of 2013 and will randomize 300 patients (2 to 1) with metastatic triple negative breast cancers that over-express GPNMB and who have previously received anthracyclines and taxanes. The study is a direct comparison of CDX-011 versus capecitabine, also known by the trade name Xeloda®. The primary endpoints for this accelerated approval study will be overall response rate and progression free survival. The study is designed to enable Celldex to apply for registration with positive results for either endpoint. An interim analysis (futility assessment) will be conducted after the enrollment of the first 80 patients.
Sentiment: Strong Buy
This is probably the best posting I've read on YMB. Not because I agree with the logical and sentiment (disclosure- I do) but because it is informative, logical and factual. Thank you all for your insights.
$70 is not possible this year unless a data release indicates a near-cure for cancer (and there's almost no chance of that).
I have stated that I believe very positive 1127 data will cause CLDX to trade in the low $40s and very positive Rindo data two weeks later would lift CLDX to the high $40s. If both of those data releases are very positive, I believe CLDX will close this year at about $49.
Next year (2014), if the Rindo ReACT expansion data supports early approval then we're looking at a share price close to $90 in the second half of the year. The share price at the end of the year would depend on the timetable to FDA approval.
Sentiment: Strong Buy
whipper, I agree with you. Wedbushes upgrade with various price targets is why agree with that scenario, in addition with many high target upgrades. I was lucky enough to sell some shares between $30 - $35. Bought back shares at $26 and now will hold for the leg up. Maybe sell trading shares in high $30s ..... Twitter has a ton of cldx traders talking about buying selling $1 up down up down....damm dont know how these guys do this all day, and do they make that much money trading daily? Some have no idea what cldx even is or has !
They are flies in the ointment that will quickly drown. I have NO respect for them, playing the 1.00 or two up or down. You are right, they have no clue, they simply have no interest except a quick F in and out. The tremdous strength and fundamentals of this company will be more than rewarding for those who continue to buy/hold. I definitely see 70.00 as succinct possibility if not significantly more 100+ by end of 2014. If the market is convinced shall we say of the safety profile and phase I results on 1127 and it begins to command the attention it and 1135 (game-changers in how cancer immunotherapy is effectively implemented) then we will double very very quickly from 30
I'm still in it for the long run even tho i lost all my profits, lol. I was up like $20,000, then couple days before the gov't shutdown i had bought an aditional 1000 shares, giving me a total of 2000 shares. Can't believe how fast I lost $20,000 lol. I should of waited on that purchase and payed more attention to the news and the market. but oh well It's ok tho, this is how i'm learning, by making expensive mistakes... I have faith in this company, just not our government. I don't how how you guy's go about doing all this research on these companies. I wish i had the time, but i've been back in school ever since i got laid off. I learn from you all by coming on this board and reading the posts.I just hope our government gets it's F'in #$%$ together, so the markets can get back to normal.
I don't know how these day traders do it either. buying and selling everyday, Don't their profits take a hit by the capital gains? I use my IRA to trade, we're not allowed to make those kinds of trades.
I just hope i make back my 20g's and then some... =D