Assume that everyone in this board are stage III NSCLC patients and at the same time are also ONTY stock investors, with all the knowledge we have, particularly the recent published abstract of the START trial, now let me know who can be called a pig: [a pig is a shameless, and hypocritical person who does not follow his or her conscience:
Some thinks, oh, well, I don't want FDA to approve L-BLP25 because I have some doubt on this and that, bla, bla and bla, and I would rather wait for my end day;
Some say, I would like FDA to approve L--BLP25 now and would like to take some risks to have a potential one more year of invaluable life with better quality.
It is clear when everyone follows his or her conscience, they all want FDA to approve L-BLP25 and are willing to have the shot of hope as juncky used to say.
Additionally, based on the current situation of how these patients are treated, anyone including oncologists would have the same opinions as the real patients.
In a sense, waiting for five or ten more years to approve L-BLP25 is equivalent of "killing tens of thousands of people" right away.
Yes, Arhdan. They deserve being called that if they play politics or any kind of game for own financial gain at the cost of patients. Let get a refresh with this, courtesy of Dr. Kirkman:
" Analysis of START trial demonstrated that in a pre-defined subgroup of patients receiving initial concurrent chemoradiotherapy, the median overall survival was 30.8 months in the L-BLP25 group versus 20.6 months in the placebo group, a clinically relevant improvement of over 10 months and with a hazard ratio of 0.78.
This group was a predefined group based on one of the randomization strata for the trial. This means that the randomization of the subgroup should be valid. It's always possible that there are some relevant factors which are not equally distributed between the groups, but at present, one has not been identified.
The group was very large. There were 806 patients on this subgroup, which represents about 2/3 of all the patients in the trial. As the investigator pointed out in presenting these data at ASCO, this makes the subgroup analysis alone larger than any other trial ever conducted in Stage III lung cancer.
The result was statistically significant, with a p-value of 0.016. At present, we do not yet know if our partner for L-BLP25, Merck Serono, will proceed with additional trials. We do know that they are in the process of discussing the data with regulatory authorities and key opinion leaders to make the determination. We also know that other trials of L-BLP25 are continuing. The INSPIRE trial of Phase III trial in Asia, similar in design to START, has been modified to only include patients receiving concurrent chemoradiotherapy and is ongoing."
No any term I can come up with these "white criminals" who "murder" their patients by denying them of the most promising and advanced treatments.
No safety issues, and 10 plus months of living advantages plus better quality of lives. What the hell are they looking for?
In the past they said a couple of months of advantage in the treatment compared to standard of care for advanced lung cancer patients had never heard of, which would be very significant.
Now what they are going to say? Some did say that a trial is needed for full approval. Man, what a distorted life are these people living?
When discussing "manipulation" or any similar conspiracy theory regarding ONTY stock, it is good to know that over the last three years (at least) the market has never been wrong regarding the stock price or upcoming negative events. This is NOT manipulation.....the 'market' knows what lies ahead. The 'retail' investor is clueless. I (for some bizarre reason) still own several shares of ONTY. (have sold 3/4). Watching the stock price over the last 3-4 wks I fully expect another dose of negative news very soon. Remember, whenever ANYONE from ONTY speaks about the company, the stock price falls. Kirkman speaks soon. You know what will happen.
It's ironic I have restarted a long position as Dr West twitted his impressiveness on Stimuvax. It's a shame for him to say "scientific Qs independent of realities. Guess his reality has always been crooked.
Come on, people. The data is obviously not perfect and the predetermined primary objective is not met, but the data of the significant predetermined subset is overwhelming and significant, and people have not treatment after chemoradiotherapy.
Nobody asks for outright approval, but a conditional approval on another confirmation trial is rational and reasonable and can save tens of thousands of patients each year.
Does the L-BLP25 harms people, no; does L-BLP25 show significant effect, yes it does for concordant chemoradiotherapy patients for more than 10 months longer survival.
So what makes this a complex issue?
agree, 100 % agree. reason says approve it and give the fighters a new shot of hope. the data is clear and the FDA are the ones who mucked up the overall result with that undue delay, but the ones who got c CRT , the MAJORITY, or the trial beat the standard by far. Why they can't see defies logic. I think that all the people who have lung cancer and their families should march on the halls of the FDA and bang on Pazdur's office and demand an explanation as to ezactly WHY they are holding it up! IT WORKS!