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Re: moneyRD post# 2988

Monday, 12/21/2020 8:37:01 PM

Monday, December 21, 2020 8:37:01 PM

Post# of 3283
Welcome aboard moneyRD. We can only guess what's going on. As I noted in post 2985, I was hoping a PR would have been out before now on what's going on w pozi Zenith 20 cohort 2 NDA and cohort 3 trial results. While they never said they would PR the cohort 2 pre-NDA meeting (i.e if the NDA submission is going to happen), it makes sense that they should, but historically, when SPPI sticks us w PRs at the end of the year, the news is not great but I can rationalize them doing so this time because cohort 3 needs every bit of that time for data to mature. For comparison, they didn't PR cohort 1 and 2 data till much later in data maturity and if cohort 3 was cohort 1 or 2, you would expect a PR in 6 months from now but at the beginning of this year they had pressure due to cohort 1 results at the time not meeting expectations, to issue a PR for cohort 3 before year end. So we're expecting that, and we're expecting guidance on whether they will submit a NDA for cohort 3. Still hoping for a positive PR or 2 before year end but there is precedence of bad PRs before year end. Here is hoping it's different this time.