As expected: no revelations!
Of note, though:
(1) rindo: CLDX is confident to complete enrollment into the ACT IV study "late next year".
(2) 011: encouraging feedback from the phase II investigators, want to continue to collaborate through phase III; in terms of tox: very manageable profile and no new neurotox (a known risk of the linker and cytotoxic), only exacerbation of pre-existing; in regards to FDA interactions: no details!
(3) nothing on partnering activities.
Bizzare Q&A to the Oppenheimer call today - almost like a twilight zone episode .. . It was a large room you could tell by the sound, but a room full of analysts couldn't think of anything to ask AM?? Weird. They must have either already have had an opportunity to talk informally before the meeting to get questions answered, had a planned informal discussion planned for after the meeting or they were all so stunned they couldn't believe.it was true that this left for dead biotech that Pfizer practically killed single-handed twice (once when torcetripib fell off a cliff taking Avant's CETP vaccine with it and a second time when they left Rindo at the alter) was actually looking like one of the best early biotech's out there. I really think they are paying this close to the vest to get their best clients in on this before it's too late since they currently have this at Outperform but under evaluation for upgrade to buy as nice speculative part of a growth protfolio . .. . Does anyone know if Oppenheimer clients have ability to move the needle?
We've known that Rindo data was still at least 2 years away for forever, FDA approval and marketing in around about 2016, but once the phase III program is fully enrolled, the value will start to build up to the filing and through approval. Of note, this does present a potential surprise catalyst possible durig phase III if the drug works overwhelmingly and the study is stopped early for efficacy in brain cancer. If it does work overwhelmingly, then the committee of doctors and statisticians overseeing the study may want the FDA to get the drug to patient of this horrendous disease sooner rather than later. This is not a high probability, but it is possible and has happened before in difficult to treat patients where few (if any ) viable options are available.
So, are you saying they'll nothing to present at coming ASCO? And why do they need to wait that long to submit Rindo for approval? Is not it possible just to wait for getting statistically significant OS results and not until everybody in treatment arm will die?
As far as partnering, I was hoping for some questions from the highly surprising deaf and dumb audience to in turn solicit, "Yes we are considering a number of highly attractive potential....."
But the above with INFORMATION KNOWN is a GIVEN!
oppy people are SALES people w/ very lmtd understanding of what CLDX IP is all about...I know for a fact that most CEOS hates these talks because I have discussed it w/ many in years past...these NY brokers are idiots and know NADDA about the Science of CLDX...the best talks are CCs where the various ANAL leasts call in, and evn they are le$$ FORMIDABLE than in the past...used to be that ANAL lest meant MD after your name---NOT TODAY!!!
... and the next CC will be early 2013 on our current Q-4 and I expect that to be a great call....so many UPGRADES on the books for a couple months and he will shine on where things stand!
...finally no CEO will suggest we ENROLL faster but end of 2012 for GBM is LUDICROUS w/ 150 sites WW....look for much earlier than end of '12! Its Brain Ca for Gods sake and we have 7 year SURVIVORs now!
If u have GBM w/ EGFRvIII you will ENROLL...trust me folks!
So no damage from this meeting, and if anyone sells their shares it's at the risk of missing the obvious partnership announcement that is sure to follow. And on Celldex terms.
Sentiment: Strong Buy