Tibor Keler and those silly investigators at Rockefeller thought they were finished with this study last year when they presented the results.
• CD4+ T cell responses were induced in all 3 dose groups. Responses
are consistently detectable and persisted at 12 months after last
immunization in all dose groups.
• Transient and modest CD8 responses were observed in the mid and
high dose groups
For the exact same reason Merck wants Idenix: to add a nuke to its next-generation NS5A inhibitor + Protease inhibitor combo.
mariyatrader: Yes, it is essentially old news . The two trials covered in this poster (studies 301 and 306B) were the basis for the FDA approval. The poster groups the data from the studies and provides a bit more color than previously seen. Note that no mention was made of the longer-term studies 302 and 303 that did not reach statistical significance.
delayabout: The poster presentation has no effect on the deal with Lundbeck, and should be nothing new to any company that would have an interest in acquiring CHTP. While the poster certainly doesn't guarantee future CVR payments, it does help as it draws more attention from those physicians wo will be prescribing it.
PLUG: See my Seeking Alpha article (find it in the News section of the summary) for more on the CVR payments.
Come clean Frank, have you ever really shorted a stock in such a way that you could lose real US dollars if the trade goes wrong? You used to tell us that you don't actually short the stock - just kinda make a mental note instead that you think it will go down.
Everybody and his dog has been going after that antigen for many years now. Ludwig gives all interested a non-exclusive license.
"ORPHAN LIKE INDICATIONS"
mTNBC is an orphan indication also.
In any event, I don't see how this indication with only a few CR in mice will beat the indication that is already in a pivotal trial. Even the author say the next step is test to se if OS can be improved - in MICE, not people.
Note that glemba also achieved complete responses in breast cancer and melanoma xenografts (mice) but we haven't seen that yet in humans.
"Again, you will nor receive cash for trading AT LEAST FOR 1 MONTH OR 2-3 MONTHS"
That is a bit of an exaggeration. Shareholders who do not tender their shares should receive the cash and CVR within 2-4 weeks. A fairly recent rule change for two-step mergers has essentially eliminated the possibility of a "2-3 MONTH" wait.
"I believe this conference will be big for Celldex because updated 011 efficacy data will be presented."
That will indeed be huge news as the ongoing pivotal trial will still be unblinded. Those involved will be fired and the stock will get creamed as CLDX will be forced to start a new trial.
Well, the description says the updated data will be fromthe EMERGE trial. As this study ended in 2012, don't expect anything you don't already know.
In terms of solid tumors (eg breast cancer): PFS measures the time until the tumor grows; DFS measures the time until the cancer returns after having been eliminated.
"There has been a suspiciously large number of changes to the ACT-IV site in the past two weeks..."
1. I see 5 changes in the month of July. The monthly changes prior to that were 1, 4, 4, 1, 2, 4, 1,2, 4, 2, 8, 5, ...
Five changes in the past two weeks is a high rate but not exceptional compared to the rate in earlier months
2. Besides the email or spelling corrections, some of the changes in the past two weeks were to change the status from "Not yet recruiting" to "Recruiting"
or to add new centers to the study. That doesn't look like a sign of a shut-down to me.
"Start the CVR clock "
Wind it well because we are still 2 years from when sales will be relevant.
Maybe if SIVEXTRO gets of fto a good start Cubist will bump up the current very low probability these CVRs will pay anything.
As the maximum amount is $2/CVR, I'd say you are quite the optimist.
The last estimate from Cubist was only a 4% chance of getting the full amount, and 6.5% of getting the minimum of $1.
I kept a few rights just for grins.
"...RGDX will be testing for is, you got it, EGFRIII mutations! "
You got the wrong EGFR mutation - EGFRVIII is not included in the screening.
Does this mean the NCI is not serious?
Fraz, you and the OP see "EGFR mutation" and immediately assume it refers to the only mutation you have heard of - EGFRVIII. While v3 is important in glioblastoma. it is not a player in lung cancer. When one talks of EGFR mutant in this setting everybody but this message board understands that does not include v3.
The RGDX contract is to screen early-stage lung cancer patients for two other EGFR mutations (EGFR exon 19 deletion, L858R mutation) along with an ALK mutation as part of the ALCHEMIST trial. If the tumors are positive for one of the mutations they then go on to the appropriate treatment trial. Again, there is no screening for EGFRVIII.
My NCI joke flew right over your head also. If the OP feels that the NCI is serious because he believes RGDX will be screening for EGFRVIII it then suggests that the NCI is not serious because, in actuality, they are not screening for that mutation.
BTW: Dana Farber is just one of many centers in the study and does not have a preferred position.
It's crazy as #$%$...
2 years ago..$5/share...enterprise value under $100 million and all this board could talk about was all the cancers rindo would treat and the billions from the orphan drug 1135. Now those two options are gone and it's a billion dollar company.