I'm guessing the choreography of the next week or
Post# of 154109
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Posted On: 07/24/2020 1:51:16 PM
Re: Shelly2626 #44885
I'm guessing the choreography of the next week or two is immensely complicated and much more nuanced than simply mechanically releasing the results of the M/M trial.
At the very least, the company must be asking itself:
1. How strong are "Primary", "Secondary", and "Other" endpoints in the M/M? FYI: The "Other" endpoints include Dr.BP's assays.
2. Are the M/M results, either individually or taken as a whole, strong enough to offset the low N= number?
3. How do we time and structure the media release the M/M results so that the FDA has less wiggle room to demand a larger Phase 3?
4. How do we avoid issuing a M/M press release that, once again, gets ignored by 95% of the mainstream media?
5. How do we leverage the release of the M/M results to possibly support a more favorable outcome in DSMC's safety look at the S/C?
6. How can we leverage both the results of the M/M, and the safety look at the S/C, such that the sum is greater than the parts in the eyes of the FDA?
And I'm sure there's dozens more considerations in this four dimensional chess board.
We are not in a position of leverage here. The M/M is small by any measure, and the S/C is not even half baked (more like 1/4 baked).
Anyway, my point is that it's complicated and we might not see M/M results next week.
At the very least, the company must be asking itself:
1. How strong are "Primary", "Secondary", and "Other" endpoints in the M/M? FYI: The "Other" endpoints include Dr.BP's assays.
2. Are the M/M results, either individually or taken as a whole, strong enough to offset the low N= number?
3. How do we time and structure the media release the M/M results so that the FDA has less wiggle room to demand a larger Phase 3?
4. How do we avoid issuing a M/M press release that, once again, gets ignored by 95% of the mainstream media?
5. How do we leverage the release of the M/M results to possibly support a more favorable outcome in DSMC's safety look at the S/C?
6. How can we leverage both the results of the M/M, and the safety look at the S/C, such that the sum is greater than the parts in the eyes of the FDA?
And I'm sure there's dozens more considerations in this four dimensional chess board.
We are not in a position of leverage here. The M/M is small by any measure, and the S/C is not even half baked (more like 1/4 baked).
Anyway, my point is that it's complicated and we might not see M/M results next week.
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