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Posted On: 04/30/2020 9:13:36 PM
Post# of 149993
“Additionally, in all likelihood the completion of the Ph 2 mild/moderate trial will necessitate a Ph 3 trial.”
I believe NP’s hope is that the completion of the phase 2 mild to moderate trial coincides with the interim review of the phase 2/3 severe trial. That way, he can submit both data to the FDA and request approval. Throw in data from 50+ EIND patients as well (maybe 75+ by then).
Will that result in approval? Who knows. The FDA always wants more patients but maybe with very good results we can see a phase 4.
I believe NP’s hope is that the completion of the phase 2 mild to moderate trial coincides with the interim review of the phase 2/3 severe trial. That way, he can submit both data to the FDA and request approval. Throw in data from 50+ EIND patients as well (maybe 75+ by then).
Will that result in approval? Who knows. The FDA always wants more patients but maybe with very good results we can see a phase 4.
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