Hey, Balleroni, I had a chance to go back to th
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Posted On: 05/18/2021 12:52:11 PM
Hey, Balleroni,
I had a chance to go back to the call transcript to see if my memory was right about the May 18th guidance.
The first few times Joe talked about it, he stated/insinuated the commercial run for the clinical trials would be filled (completed) on May 18th:
- "The manufacturing run for our clinical supply will be filled on May 18th at the University of Iowa Pharmaceuticals,..."
- "So, once our manufacturing of the complete vaccine for commercial use is done on May 18th,..."
- "I know over here, we have to wait until May 18th..."
- "There are tests going on every single day in the CMC space for getting our final commercial on May 18th done."
But the last time he speaks about it, he says:
- "When we were put into that slot for May 18th, but they're doing all the work that leads up to that commercial run of our vaccine; we've already done the three engineering laws, we've already done the packaging on the three engineering runs, we've already done the mixing, we've done all the testing, but now we have one last big thing which is the commercial big run, which will be done in May--started on the 18th."
So I don't think he actually told us when it would be COMPLETE, and I firmly believe that date is not May 18th. Hopefully it's still in May, as he last states.
On top of that, the stability data will take another 6-8 weeks after the run is complete. And, despite the fact he is hoping to submit the IND after the commercial run is complete, that seemed to rely on the FDA allowing them to submit and then update on a rolling basis (something he stated other companies were allowed to do last year). But who is really counting on any special favors for little old us?
I personally am steeling myself for a possible wait as long as early/mid-July for IND submission.
So the next items I'm looking for (any day now?) are the Excellagen financing, RPM updates/signings, and AZ updates.
I had a chance to go back to the call transcript to see if my memory was right about the May 18th guidance.
The first few times Joe talked about it, he stated/insinuated the commercial run for the clinical trials would be filled (completed) on May 18th:
- "The manufacturing run for our clinical supply will be filled on May 18th at the University of Iowa Pharmaceuticals,..."
- "So, once our manufacturing of the complete vaccine for commercial use is done on May 18th,..."
- "I know over here, we have to wait until May 18th..."
- "There are tests going on every single day in the CMC space for getting our final commercial on May 18th done."
But the last time he speaks about it, he says:
- "When we were put into that slot for May 18th, but they're doing all the work that leads up to that commercial run of our vaccine; we've already done the three engineering laws, we've already done the packaging on the three engineering runs, we've already done the mixing, we've done all the testing, but now we have one last big thing which is the commercial big run, which will be done in May--started on the 18th."
So I don't think he actually told us when it would be COMPLETE, and I firmly believe that date is not May 18th. Hopefully it's still in May, as he last states.
On top of that, the stability data will take another 6-8 weeks after the run is complete. And, despite the fact he is hoping to submit the IND after the commercial run is complete, that seemed to rely on the FDA allowing them to submit and then update on a rolling basis (something he stated other companies were allowed to do last year). But who is really counting on any special favors for little old us?
I personally am steeling myself for a possible wait as long as early/mid-July for IND submission.
So the next items I'm looking for (any day now?) are the Excellagen financing, RPM updates/signings, and AZ updates.
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