Clean Clinical Exam.. Now Gait Abnormality
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Nikki J
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Agree with above. Since you spoke of my initial symptom I will tell you how we differ
I had what seemed a trivial issue with my ankle. I had no gait disturbance ( unlike your report) and no issues with my calf at all ( unlike you).
I had an EMG solely because I was in a genetic study and it was scheduled anyway. I would not have called my pcp let alone a neurologist. They did not test my ankle but my leg. It was abnormal with acute and chronic denervation in both the symptomatic area and in other areas where I felt no symptoms including my calf
I had what seemed a trivial issue with my ankle. I had no gait disturbance ( unlike your report) and no issues with my calf at all ( unlike you).
I had an EMG solely because I was in a genetic study and it was scheduled anyway. I would not have called my pcp let alone a neurologist. They did not test my ankle but my leg. It was abnormal with acute and chronic denervation in both the symptomatic area and in other areas where I felt no symptoms including my calf
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NurOwn Phase III Trail -- Includes Useful Info for PALS
Chaim Libovits stated that there is no hard timeline for a RTT decision. Brainstorm stated that it's "fact gathering" stage that includes getting a new US manufacturing facility for stem cells (the facility that they are manufacturing the stem cells for Phase III does not have the capacity for an RTT production) and a getting a better understanding of this novel law.
Brainstorm has explicitly stated that only patients who do NOT qualify for the phase III clinical trial would be considered for RTT IF Brainstorm offers NurOwn before the phase III trial is complete. This implies patients who received the placebo will not be eligible.
The retail cost of NurOwn treatment is enormous for all the reasons Laurie stated. I do not see how Brainstorm goes through with RTT under their self-imposed constraint of only enacting a RTT option if there is recourse for those who cannot afford treatment. By definition, a third party MUST intercede to pay for treatment for those who cannot afford it themselves. I do not see this happening. I would not be surprised if this is ultimately the reason Brainstorm states it will not go through with offering RTT options for patients. Again, this is a self-imposed constraint.
Brainstorm has stated in no uncertain terms that their focus is completing the phase III clinical trial. Without a successful phase III trial, there is no NurOwn and possibly no Brainstorm. Any risk or cost that a RTT option exposes to the Phase III trial is literally an existential threat to Brainstorm. I hate to say that, but it's naive to think that Brainstorm is not considering this in its decision.
Also, Brainstorm confirmed that the Phase III trial has no 'hard' completion date. Brainstorm's goal is to complete patient enrollment by the end of 2018, and the trial concludes 11.5 months afterward. Meaning that Phase III will tentatively conclude at the end of 2019 or early 2020 by current estimates.
Chaim Libovits stated that there is no hard timeline for a RTT decision. Brainstorm stated that it's "fact gathering" stage that includes getting a new US manufacturing facility for stem cells (the facility that they are manufacturing the stem cells for Phase III does not have the capacity for an RTT production) and a getting a better understanding of this novel law.
Brainstorm has explicitly stated that only patients who do NOT qualify for the phase III clinical trial would be considered for RTT IF Brainstorm offers NurOwn before the phase III trial is complete. This implies patients who received the placebo will not be eligible.
The retail cost of NurOwn treatment is enormous for all the reasons Laurie stated. I do not see how Brainstorm goes through with RTT under their self-imposed constraint of only enacting a RTT option if there is recourse for those who cannot afford treatment. By definition, a third party MUST intercede to pay for treatment for those who cannot afford it themselves. I do not see this happening. I would not be surprised if this is ultimately the reason Brainstorm states it will not go through with offering RTT options for patients. Again, this is a self-imposed constraint.
Brainstorm has stated in no uncertain terms that their focus is completing the phase III clinical trial. Without a successful phase III trial, there is no NurOwn and possibly no Brainstorm. Any risk or cost that a RTT option exposes to the Phase III trial is literally an existential threat to Brainstorm. I hate to say that, but it's naive to think that Brainstorm is not considering this in its decision.
Also, Brainstorm confirmed that the Phase III trial has no 'hard' completion date. Brainstorm's goal is to complete patient enrollment by the end of 2018, and the trial concludes 11.5 months afterward. Meaning that Phase III will tentatively conclude at the end of 2019 or early 2020 by current estimates.
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Can I ask a question... what was all of that for?
In just a couple sentences... what's the point you're trying to make?
In just a couple sentences... what's the point you're trying to make?
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BeachBum
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Sorry for confusion, my last comment is in regards to the thread below. I am not permitted by forum Moderators to post in any other thread except this one, but I'd like to comment on the topic.
https://www.alsforums.com/forum/als-drug-trials/41146-nurown-stem-cell-phase-3-study-6.html
There are a few points I'm making:
1.) Brainstorm is still 'fact-gathering' before making a decision about RTT offering. No deadline for decision.
2.) RTT offering would only be available to PALS who did not qualify for Phase III clinical trial.
3.) Brainstorm's self-imposed affordability condition for RTT makes it impossible without a third-party accommodating the costs of those who cannot pay independently.
4.) A RTT offering may introduce costs/risks that can jeopardize Brainstorm's future.
5.) Phase III conclusion is open-ended, but currently estimates at the end of 2019.
https://www.alsforums.com/forum/als-drug-trials/41146-nurown-stem-cell-phase-3-study-6.html
There are a few points I'm making:
1.) Brainstorm is still 'fact-gathering' before making a decision about RTT offering. No deadline for decision.
2.) RTT offering would only be available to PALS who did not qualify for Phase III clinical trial.
3.) Brainstorm's self-imposed affordability condition for RTT makes it impossible without a third-party accommodating the costs of those who cannot pay independently.
4.) A RTT offering may introduce costs/risks that can jeopardize Brainstorm's future.
5.) Phase III conclusion is open-ended, but currently estimates at the end of 2019.
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So, where are you going with all this?
You've had several very very knowledgeable members, Nikki, Laurie, Karen, Kim, Fiona
and first hand experienced CALS say... you do not have ALS.
So... what for? Am I missing something here?
You've had several very very knowledgeable members, Nikki, Laurie, Karen, Kim, Fiona
and first hand experienced CALS say... you do not have ALS.
So... what for? Am I missing something here?
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BeachBum, everything you noted is indeed public knowledge. As for placebo patients benefiting under RTT, no, they would not be eligible -- I was making an ethical point, perhaps overly esoteric. It's moot because no one should be booking tickets for any RTT therapy.
So we are not adding anything new here. Please don't shoehorn any topics into this one apart from your own situation, which appears to be radiculopathy, for which PT is usually first line treatment. Please contact your neuro with any further questions, one of which might be the treatment plan to address your symptoms.
Being cleared of ALS is a great thing. And while we appreciate your interest in NurOwn, I am sure there is some way you can further the cause of awareness outside these Forums. Please be considerate of those here who do not share your good fortune.
Best,
Laurie
So we are not adding anything new here. Please don't shoehorn any topics into this one apart from your own situation, which appears to be radiculopathy, for which PT is usually first line treatment. Please contact your neuro with any further questions, one of which might be the treatment plan to address your symptoms.
Being cleared of ALS is a great thing. And while we appreciate your interest in NurOwn, I am sure there is some way you can further the cause of awareness outside these Forums. Please be considerate of those here who do not share your good fortune.
Best,
Laurie
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