From the last CC: - NP represented that after dis
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Posted On: 03/20/2021 11:40:39 PM
From the last CC:
- NP represented that after discussions with the FDA and other international regulatory bodies, the “path forward had been defined”
- “For conditional approval, the drug company must show that the drug has a “reasonable expectation of effectiveness,” but has not yet proven that it meets the “substantial evidence” standard of effectiveness for full approval.”
So NP is following their guidance.
- File for conditional approval immediately to begin usage of LL.The results along with the doctors opinions involved in the tests, and the FDA’s guidance should result in approval shortly
- CD-16: 3 to 4 month duration, 140 patient expansion of CD-12 exact protocol with a 50/50 dbl blinded distribution to minimize distribution aberrations. This should provide the additional data to augment the CD-12 results.
Tomorrow, we will hear of their progress. GLTA
- NP represented that after discussions with the FDA and other international regulatory bodies, the “path forward had been defined”
- “For conditional approval, the drug company must show that the drug has a “reasonable expectation of effectiveness,” but has not yet proven that it meets the “substantial evidence” standard of effectiveness for full approval.”
So NP is following their guidance.
- File for conditional approval immediately to begin usage of LL.The results along with the doctors opinions involved in the tests, and the FDA’s guidance should result in approval shortly
- CD-16: 3 to 4 month duration, 140 patient expansion of CD-12 exact protocol with a 50/50 dbl blinded distribution to minimize distribution aberrations. This should provide the additional data to augment the CD-12 results.
Tomorrow, we will hear of their progress. GLTA
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