1904 – Russo-Japanese War: Battle of Port Arthur concludes.
1913 – A group of meteors is visible across much of the eastern seaboard of North and South America, leading astronomers to conclude the source had been a small, short-lived natural satellite of the Earth.
1920 – Under the terms of the Svalbard Treaty, international diplomacy recognizes Norwegian sovereignty over Arctic archipelago Svalbard, and designates it as demilitarized.
1922 – Brazil becomes a member of the Berne Convention copyright treaty.
1934 – The Balkan Entente is formed.
1930 – Yên Bái mutiny in French Indochina
1933 – In round 13 of a boxing match at New York City's Madison Square Garden, Primo Carnera knocks out Ernie Schaaf. Schaaf dies four days later.
1936 – Second Italo-Abyssinian War: Italian troops launched the Battle of Amba Aradam against Ethiopian defenders.
1939 – Spanish Civil War: The Nationalists conclude their conquest of Catalonia and seal the border with France.
1940 – The Soviet Union begins mass deportations of Polish citizens from occupied eastern Poland to Siberia.
1942 – The first gold record is presented to Glenn Miller for "Chattanooga Choo Choo".
Certainly is setting up well for an excited PR on the 10th that the DMSB recommends the trial proceed.
Somebody tell Biden not to waste money searching for a cure, CLDX is already there?
I wonder why the trial was not stopped at the first interim analysis in that case.
"Vice President Joe Biden, charged by President Barack Obama to lead government efforts to find a cure for cancer, will discuss his plans next Wednesday at the Duke University School of Medicine, his office said.
Vice President Joe Biden, charged by President Barack Obama to lead government efforts to find a cure for cancer, will discuss his plans next Wednesday at the Duke University School of Medicine, his office said."
If these cancer cures envisioned by Biden are successful it would be bad news for CLDX products, no?
"Yes, and she is easy on the eyes too."
That's important for pharmaceutical sales. Always wondered how Frazz got the job selling Cipro.
Or was he once a stud but had to let go when lost it after age 55?
"At the 8/05 "
Should read "At the 8/2015...."
"You write like this old news"
Change the "old" to "new" ---- Ed.
Check the Celldex Investor day presentation from 2012(?). They discuss the program and even show some pictures.
There was also some data from the expanded access program that was included in a press release concerning trial results a while back.
Basically the FDA agreed years ago that the compound has a a chance to offer help and that it is not too dangerous relative to the disease. That is all the FDA has determined.
Requirements from the FDA website:
Ensuring patient safety is a priority - FDA must determine that the potential patient benefit justifies the potential risk of the expanded access use of the investigational drug, and that the potential risk is not unreasonable in the context of the disease or condition to be treated. Even with safeguards, there may be significant unknowns about safety and effectiveness.
Patients should understand and be willing to accept the possible risks and unknown effectiveness associated with the investigational medical product. Patients generally will need to sign an informed consent form in order to receive the investigational drug.
The patient’s physician must determine that the probable risk to the patient from the investigational drug is not greater than the probable risk from the disease or condition.
You write like this old news, but hasn't the compassionate use program been in use for years?
As you have pointed out here, interesting results from this program were part of the impetus for the ReAct trial.
At the 8/05 conference call,Tom Davis touched on the subject:
"Well, certainly based on the data, there’s been a great deal of interest, Joe, around both recurrent patients and upfront patients receiving RINTEGA. Obviously, our resources are not unlimited and we have a program for investigators who have participated in previous studies to refer patients in. And where possible, we can provide support, but there are still limitations.
More importantly though, we are planning some additional studies looking at new combinations with RINTEGA and different scientific questions, and we hope to be able to put patients on trials rather than providing compassionate use before too long."
It's not that sad - the FDA has nothing to do with interim analysis.
I believe that Nick wished to remind us that his own dribble is useless as the the AF p-values are fine while Nick's are way off.
If we should later learn that your p-values are not correct than we can likewise infer the rest of your dribble is useless?
"2. There is misleading story...that this means that Rindo is ineffective and the trial will fail..."
The author should have contacted an expert instead of just quoting an unnamed short trader. The chance of trial success if given the green light to proceed to completion after two interim looks can be quantified if you make assumptions about the true HR. We already know it is 95% if HR=0.79 as that is how the trial was designed. With that high of an HR, however, the odds of an early stop now for efficacy (as would happen if the these early patients performed much better than the full trial population) is quite low.
As best I can follow the theory, using efficacy estimates based on Ph. II data leads to the trial most likely continuing to the end, with an early stop next most likely, and a small, but non-zero chance of stopped for futility even if the full data set would show efficacy.
If I wanted to join the conspiracy folks here, it does almost look like we are being set up to believe the most likely announcement is very bad news when in fact it is not.
Tell that to Sampson etal
Immunologic escape after prolonged progression-free survival with epidermal growth factor receptor variant III peptide vaccination in patients with newly diagnosed glioblastoma
J Clin Oncol. 2010 Nov 1;28(31):4722-9
"There has been ZERO evidence of any recurrence or anyimmunologic escape."
I'm pretty sure at least a few patients progressed and some may have even died.
"$4 CVR if their new drug get approved by 2019"
It is actually more difficult than that. Needs to be approved WITHOUT a boxed warning or the FDA requiring a risk
evaluation strategy. No longer a slam dunk with those restrictions.
"such approval (a) must not require the inclusion of a “boxed warning” (as defined in 21 CFR § 201.57(c)(1)) in the product labeling, (b) must not require the implementation of a risk evaluation and mitigation strategy with elements to assure safe use required by the FDA under the authority granted to it in 21 U.S.C. § 355-1 other than one whose elements are limited to the distribution of educational materials and (c) must not be granted by the FDA under subpart E of the Federal Drug and Cosmetic Act (21 CFR § 601)."
"not an easy study to enroll"
Those are the relaxed standards that were put in place after the slow enrollment with the original requirements. The current requirements are not tough. A lot of competition for these patients in other trials, however.
game changer indeed.. No longer possible to grab cheap shares from "confused...and concerned..." retail investors.