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that has always been my main (other than funding) question.
why so very few patients? far too few to be statistically significant surely?
I can't rememebr the details but wasn't the 201 trial meant to go to multiple hospitals in the UK (up north somewhere I seem to remember). I assume this never happened.
Maths, the last official presentation we saw included patient "#11" in the 4mg group.
If the trial data now says 18 fully completed, and I think there were 3x patients in the 4mg (i.e. the end). That makes 7 patients dosed in the 5mg, 8mg + random escalation study, that we have not seen data for.
OK it's not huge, but it might be enough.
If Satu seriously cannot get to the end of the 201 dose escalation 1/2a trial, without lining up a potential partner willing to put money on the table, frankly she should just resign. There has been plenty of time to put a deal together without trying to force another equity round on us in a panic.
It was the 401 patients that all died.
I believe there were 4 patients that continued to the escalated dosing stage of 201, so that would make 10 (max) on last part of 201 trial.
from memory - did not all of them die?
it is **** to watch family members die?
I've found the March 2017 report on their website. Only 8 patients reported on. At least 11 recruited by then so some patients excluded.
What a difference having 50 enrollments would have made!
I am not clear of the implications although at least there has been an update. Time will tell....(hopefully).......
Interesting update to clinical trials site.
They were still recruiting in July 2019, but would be no reason to update just to say recruitment had stopped. So study is now complete. But notice that only 18 were ever recruited, not the 50 anticipated. Will 18 be enough to get any meaningful efficacy data? It's better than 7(!!!)
(how many were reported on ages ago when we last had any actual data?)
Sorry. folks, I'm not too hopeful for good news, now. Like 401 it may be very hard to convince anyone to take the trials further.
Nomlungu, I guess that makes logical sense, but leaves the question as to whether the trial itself has been completed open. Oh well fingers crossed and let's see what happens over the next few weeks.
Bankfool,
I was just putting PAD004's comment about an update into perspective - the recent update that he referred to is anomalous. If the trial has been completed then they are no longer recruiting patients.
Hi nomlungu, the page I was looking at says actual study completion date 27/1/2020
https://clinicaltrials.gov/ct2/show/study/NCT02280317
The link you posted does indicate that it was recruitment has been completed.
Did I misinterpret what I saw? I was excited for a moment
Yes that is definitely a good bit of detective work, well done. It says the completion date was 27/1/2020. Not sure how long it might take to publish the results, would be great if it could be published by mid March. Not sure if it will be boom!, but it could be a step in the right direction. Fingers crossed
So they have stopped recruiting for the trial - as the Actual Primary Completion Date was January 27, 2020 the 'fact' that they have stopped recruiting means little. The change log on the trial is below:
https://clinicaltrials.gov/ct2/history/NCT02280317
That’s very interesting. I looked up the site but I will need some additional time to study.
You know out of this disaster could emerge triumph. Hope I haven’t sold off the majority too early. But hell if so that’s life. Just dreaming.
Thanks for that link.
SL100-even thought he submission date says 14th Feb this was only published online today.....It was not there yesterday or the day before when I checked.
Hi- that’s a good piece of ‘detective’ work. Well done
It would have to be fantastic news for it to be of any consequence to me, I’m 98% down in here.....
An update has been issued on clinicatrails.gov for 201!!!!!!!!
Here we go perhaps???????????