RE:90 Day Period & 180 Day Period 99942Apophis wrote: Newsletter dated November 29 had patients 25 to 30 being treated from the previous Newsletter dated August 30/2021 a time-frame of 3 months. A reasonable assumption would be 2 patients treated per month.
We are now approaching the end of January/2022 which of course is 2 months since the last Newsletter or 4 of the 6 ( patients 25, 26, 27 & 28 ) that were announced treated should have hit that 90 point.
The 90 day end point I believe is plus or minus 7 days!
Looking at the 180 Day we had in the Newsletter of August 30/2021 patients 21 to 24 treated from the previous Newsletter dated June11/2021. That gives us 2 months 3 weeks, lets just say 1 patient for June and 1 for July with 2 for August. That would now put patients 21 & 22 hitting their 180 point at the end of January/2022.
End of February to first week of March in my opinion is Newsletter territory, however news of material substance could be released at any time.
Can't see them being allowed to count any of the first 12 patients treated because of the gross under treatments they received. The only ones they can count are those correctly treated twice as specified for the clinical trial. All others are merely talking points and additional information, not properly treated Phase II trial subjects. Same for the information about the long term results for the two surviving Phase I trial subjects, nice to know, but don't count formally for anything in Phase II.
i awouldn't hold my breath expecting a BTD submittal until they have 20-25 legitimate Ph II trial subject results for 90 & 180 days.