Sunday, April 02, 2017 1:39:59 PM
Well yes and no.
There was an abstract put up back in December when I first noticed and posted here. I cautioned everyone at the time that it was a place holder as it didn't really give much more than we already knew except for the potential of their cognitive function to have at least stabilized at baseline. As well, if you had looked at the conclusion, they say 12 months instead of 15 which was another clue that it was an incomplete abstract and merely holding a spot. The abstract was pulled well in advance of this conference for whatever reason and there was no official PR that they would have this data presented at this conference.
To say that there would be a definite 15 month update is absurd. At no point has the company said that they would update you every 3 months. The clinical trials document clearly says they would do measurements at those time points. However the "study results will be presented at a scientific conference and/or published.", but it does not make any mention of frequency. If they wanted to, they could wait until the end of the extended trial before they give you anything. Unless someone here can give us a direct quote from Missling stating that he would announce results concurrently with measured points.
Either way of how anyone feels about this 15 month data, this conference has passed and it is also time to move on from it.
To your point about extra credit, I think you're being short sighted on the motivation of this. Primary outcome is to assess "treatment-related adverse events as assessed by CTCAE v4.0." I think you would be surprised as to how many fundamental medications have unknown long term adverse effects that we only seeing now. Safety is a key component, and if effects are seen that are serious enough to give that dreaded black box labeling or even being pulled, it would be a detrimental blow to the company as they really only have at the moment, one compound to treat many diseases. There are other considerations to be made with patient's co morbidity and potential drug interactions that can have adverse effects. PK/PD data will be, as Missling put it, the cornerstone of this trial. I am not exactly sure how they will use everything but if it comes down to precision medicine, then they will look at everything that they can with all the data they can get to ensure that the next trial gives them the best chance at success. Inclusion and exclusion of patients on that data is what they are gunning for. A poorly designed trial is just as bad as a drug that does not work or harms people. Just ask Lilly and Biogen about that.
I do agree that there is frustration from this board about trials starting and who will end up paying for all of them. That I do not have an answer for and I don't think anyone else will except for Missling himself.
The stage is not where the magic happens, it is all the relentless hours of hard work and sacrifice to create that magic. The stage is just a reflection of that. Up to you as to what you want to believe.
There was an abstract put up back in December when I first noticed and posted here. I cautioned everyone at the time that it was a place holder as it didn't really give much more than we already knew except for the potential of their cognitive function to have at least stabilized at baseline. As well, if you had looked at the conclusion, they say 12 months instead of 15 which was another clue that it was an incomplete abstract and merely holding a spot. The abstract was pulled well in advance of this conference for whatever reason and there was no official PR that they would have this data presented at this conference.
To say that there would be a definite 15 month update is absurd. At no point has the company said that they would update you every 3 months. The clinical trials document clearly says they would do measurements at those time points. However the "study results will be presented at a scientific conference and/or published.", but it does not make any mention of frequency. If they wanted to, they could wait until the end of the extended trial before they give you anything. Unless someone here can give us a direct quote from Missling stating that he would announce results concurrently with measured points.
Either way of how anyone feels about this 15 month data, this conference has passed and it is also time to move on from it.
To your point about extra credit, I think you're being short sighted on the motivation of this. Primary outcome is to assess "treatment-related adverse events as assessed by CTCAE v4.0." I think you would be surprised as to how many fundamental medications have unknown long term adverse effects that we only seeing now. Safety is a key component, and if effects are seen that are serious enough to give that dreaded black box labeling or even being pulled, it would be a detrimental blow to the company as they really only have at the moment, one compound to treat many diseases. There are other considerations to be made with patient's co morbidity and potential drug interactions that can have adverse effects. PK/PD data will be, as Missling put it, the cornerstone of this trial. I am not exactly sure how they will use everything but if it comes down to precision medicine, then they will look at everything that they can with all the data they can get to ensure that the next trial gives them the best chance at success. Inclusion and exclusion of patients on that data is what they are gunning for. A poorly designed trial is just as bad as a drug that does not work or harms people. Just ask Lilly and Biogen about that.
I do agree that there is frustration from this board about trials starting and who will end up paying for all of them. That I do not have an answer for and I don't think anyone else will except for Missling himself.
The stage is not where the magic happens, it is all the relentless hours of hard work and sacrifice to create that magic. The stage is just a reflection of that. Up to you as to what you want to believe.
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