i am also in the camp that it happens in 2022, for 2 reasons:
1. this is the team's #1 focus, per the last 2 calls - "all hands on deck". and this is a focused team now, so i think they are / have made significant progress and want to clean this off the slate before we go into the new year. And Cyrus wants to put some near-term points on the board i believe.
2. while i am wary (like others) of the FDA and their response time, this process seems pretty straightfoward - as we're simply proving the deaths were not the result of LL, but rather of pre-existing conditions. Not to minimize - but that's a whole different animal than an involved process like a BLA. And i do believe they will respond more favorably to the team now (with Cyrus) vs. to NP, where there was clear tension.
i'll be surprised (and disappointed) if this isn't resolved in 2022 - i really believe it will.
1. this is the team's #1 focus, per the last 2 calls - "all hands on deck". and this is a focused team now, so i think they are / have made significant progress and want to clean this off the slate before we go into the new year. And Cyrus wants to put some near-term points on the board i believe.
2. while i am wary (like others) of the FDA and their response time, this process seems pretty straightfoward - as we're simply proving the deaths were not the result of LL, but rather of pre-existing conditions. Not to minimize - but that's a whole different animal than an involved process like a BLA. And i do believe they will respond more favorably to the team now (with Cyrus) vs. to NP, where there was clear tension.
i'll be surprised (and disappointed) if this isn't resolved in 2022 - i really believe it will.
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