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I disagree, I definitely think the peer review, if it is good will boost the sp, and put us in the spotlight.
Much appreciated Pmjh and TommyD.
Gla
Doing it in 20 countries will speed up things up for us and provide a wide range of data, which is exactly what we need. If things happen on time and everything goes as well as phase 2, i am expecting the trial to be cut short and results/approval latest by jan. Home trial data in december will be a nice bonus, and will give us an option to give the drug to care homes etc which on its own is a huge potential in sales.
Have to agree with Joey D - the peer review for Phase II is far less likely to change anything (including the SP) unless any mistakes have been made. But then why would the powers that be give a big green light to a phase III in 20 countries if they thought that was the case? All looks and sounds good so far
We have a green light on a fast track Phase 3 trial with the FDA, the peer review is trivial now.
cheers. much appreciated....yes bit of a red herring.
Bamp, I have been involved in a fair number of papers that went for peer review and none were done insider 6 months. Obviously this is a different situation but for peer review all the data has to be reanalysed. It is not something that happens quickly as generally the reviewers have their own work they are undertaking and I suspect in this case it will also be revolving around covid. The peer review will not make any difference to the approval process.
If the FDA thought the data was rubbish we wouldn’t be doing a phase 3. This whole peer review thing was bought up by the journalists at the July 20 press conference and seems to have stuck.
I recon P3 will be filled within a week once it goes live in November. Then just 4 weeks after that we should have some preliminary results.
There are 26k new cases in UK alone, surely we can close the fecking home trial and 900-P3.
Patients recruited will start on treatment pretty well straight away as they will have COVID disease. So the limiting factor will be the speed of recruitment. As I understand it the hope is that enough patients will be recruited to reach target numbers around the end of the year and finish treatment some time in Jsnuary with results in February.
graking, there was a hint by richard in the proactive interview. Yes, I would have expected the phase 2 peer review by now (though i am ignorant of how much time is needed) but surely they would not plan for phase 3 unless they were very confident the full results were acceptable??
As soon as people are accepted (less than 72 hrs after testing positive) I assume they will be getting the drug/placebo out asap so I would assume they will start the trail and will be recruiting until it's full
They have not said. Mentioned in their early Sept RNS that their interim Phase 2 trial showed the product to be safe. Since then complete silence on trials, results or dates though the recent share issue indicates that they need the cash for, inter alia, Phase 3 trials . My magnanimity tells me they are planning a multi layer announcement a the end of trials advising of results and partnerships. My less generous view is that there as to be some reason why, by now, they have not announced the Phase 2 trial results though collecting and reviewing multi national data does take a while. If nothing by early November then I will be worried.
Hi all, can someone tell me when phase 3 is scheduled to start and end. I have just watched the video with Katie and unclear is November the start of recruitment or start of the actual trial? Or is it pretty much done simutaneously?