I dare say, SCR, if you had v3GBM, you would want Rintega, and sooner rather than later.
Frank, Though he did mention compassionate use through existing investigators, and that is how a limited number of patients can be treated for now, I thought Tibor was quite clear about exploring Rintega in other combinations within Celldex's IP. I floated this question to LongVrts some time ago of Rintega combination trials with other Celldex compounds, at the time, he thought it quite likely. I think this is a good follow up question for IR, for clarification.
For the life of me, I can't understand holding up conditional approval of Rintega in recurrent v3GBM, while we wait for additional supporting data from Act4. With such a death sentence, and the fact that Rintega does NO HARM, yet shows significant evidence of efficacy, why would they not err on the side of potentially extending more GBM patient's lives, and quality of those lives, while we wait for further proof of efficacy? Sounds rather unethical, under the current circumstances. I see this as more of a government bureaucratic issue than a scientific/efficacy/safety issue. Someone needs to get more aggressive in their approach regarding early, conditional approval.
So, you don't think saying it is going to 13 is guess work? More like wishful thinking actually.
Like2, the move down was due to disappointing news, but changes nothing longterm, and, (wait for it) the conversation about possible conditional early approval in recurrent v3GBM continues. Celldex is simply not counting on it, and has moved on to full approval while talks continue. Not the end of the world, unless you have v3GBM, and can't get the treatment that works best.
Hey leftist bigot, your girl Hillary is in significant trouble, both politically and criminally.
It's going to look rather political if the don't charge her with a crime, after they did so with General David Petraeus for something similar. I wonder how many false statements she has given to the FBI, and to the judge handling the court case in question.
"Supplemental Approval", when/if the FDA gives Celldex the right signal, Celldex will submit a Supplemental NDA for conditional approval. Celldex did not like the FDA's "initial response" to accelerated approval.
Celldex has not given up on ReAct, but they are smart enough to work both angles. Don't be surprised if you wake up one day to a press release on ReAct and a submitted NDA for Recurrent v3GBM. What is needed here is a little pressure from those that need Rintega.
In other words, the fat lady is not singing yet. I suspect the FDA will hear, and should hear from a few families that need Rintega now. Celldex Brass said the interest in Rintega for recurrent and first line v3GBM treatment is really growing. The FDA needs an enema, and I am sure a few suffering families may be willing to give it to them.
Dunkinnoring, Celldez said the conversation about accelerated approval is still ongoing and robust, but they also said they think it is likely Act4 "data set" (translate that meaning) is likely needed for approval, and ReAct data will be used for for full approval in both recurrent and first line, if Act4 is confirmatory, and they expect that it would be.
First look at Varli interim results is in mid-year 2016, and you know there will be talk prior to that, as patient progress will be rather fast and lasting in such combination. And you don't think others will want Celldex? Think again...
They believe so much in varli, that they are combining it with just about everything.
With a safety profile and efficacy like it has, why not? I could eventually see healthy people seeking such an immune boost, at some point. I'm just saying..., if it continues to prove safe. Think of it as a cancer blocker, a vaccine of sorts.
During the August 2015 cc, Dr Tibor Keler, while answering a question about Rintega and compassionate use while we wait for more difinitive answers from the FDA on ReAct and possible accelerated approval ("no definitive answer given to date"), and while also waiting for data, and final data on Rintega’s p3 trial ACT4, Dr Keler states “our resources are not unlimited”, and though we have a program for compassionate use, “more importantly though, we are planning some additional studies looking at new combinations with Rintega and different scientific questions, and we hope to put patients on trials, instead of compassionate use, before too long.”
This chapter of Celldex is still being written.
Rintega + Varli + 301 + 1401 ? Pick your combination. "Rintega, only better"
"Cartwright is also a leading advocate for the phased and verified elimination of all nuclear weapons worldwide ("Global Zero (campaign)"). In October 2011, he spoke at the Global Zero Summit at the Ronald Reagan Presidential Library in Simi Valley, California, and currently serves as Chair of the Global Zero U.S. Nuclear Policy Commission, which in May 2012 released its report, "Modernizing U.S. Nuclear Force Structure and Policy," calling for the United States and Russia to reduce their nuclear arsenals 80% to 900 total weapons each, which would pave the way to bringing other nuclear weapons countries into the first-in-history multilateral nuclear arms negotiations.
In June 2015, Cartwright was a signatory to a public letter written by a bipartisan group of 19 U.S. diplomats, experts, and others in June 2015, on the then-pending negotiations for a agreement between Iran and world powers over Iran's nuclear program. That letter outlined concerns about several provisions in the then-unfinished agreement and called for a number of improvements to strengthen the prospective agreement and win the letter-writers' support for it. The final agreement, concluded in July 2015, shows the influence of the letter."
Okay Cy, here is the first on on the list, and an obvious supporter of leftist causes.
"In June 2013, it was reported that Cartwright had received a "target letter" from the U.S. Justice Department, informing him that he was under investigation for leaking classified information about Stuxnet, a computer virus used in a U.S.-Israel cyberattack against centrifuges in Iranian nuclear facilities (see Operation Olympic Games). Federal investigators suspect that Cartwright leaked details of the operation to a New York Times reporter.
In March 2015, the Washington Post reported that the sensitive leak investigation, led by Rod J. Rosenstein, had "stalled amid concerns that a prosecution in federal court could force the government to confirm" information about the highly classified program. U.S. officials feared that if classified information were revealed in any information, it would harm U.S.-Israeli relations and would also complicate the then-pending negotiations on an agreement with Iran over the nuclear program. It was reported that federal prosecutors had discussions with the Office of White House Counsel, then led by Kathryn Ruemmler, on whether certain material important to the case would be declassified, and Ruemmler conveyed that the government was unwilling to provide the documentation.
Cartwright denies any wrongdoing; his attorney, Gregory B. Craig, said in March 2015 that Cartwright had no contact with federal investigators for over a year. Craig stated: "General Cartwright has done nothing wrong. He has devoted his entire life to defending the United States. He would never do anything to weaken our national defense or undermine our national security. Hoss Cartwright is a national treasure, a genuine hero and a great patriot.""
Keep in mind, the last paragraph was written by Cartwright's attorney. So take it with that in mind.
Do we have to do this with everyone that signed the letter supporting this BHO disaster?
Dunkin, he was for it, before he was against it. Or is it he was against it, before he was for it. Oh, I don't know, It's hard to keep up with the lies.
produce this list of names cy, should be easy for you. Let everyone see who they are.
Every military has its leftist loons, and hind-part kissers, J20, even at the top. Lets see if cy will produce the list.
Hey, Cy, Name those retired military persons who support what BHO is doing. I look forward to doing some research on who they are, and why they support the strengthening of the tyrannical mullas of Iran. Are they the same retired military persons that supported the retreat/abandonment in Iraq?
Zorbs, glioblastoma is a difficult nut to crack. AM, and Celldex are the first to make significant progress in this most difficult area of oncology. That said, keep your eye on varli, and other parts of the pipeline as well. And remember, Rintega will likely be paired with two other drugs in the Celldex pipeline, and will likely have much better results in those combo trials to come. How long are you willing to wait for the $8billion horse to come in? I am speaking of varli of-course.
Yes this sucks, but I would not be out too long, much will over the next 12 months. IMO