4157 P3 trial profile amendment | MRNA Message Board Posts


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Msg  18367 of 18406  at  10/19/2023 10:15:27 AM  by

dar200


 In response to msg 18354 by  dar200
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Re: 4157 P3 trial profile amendment

New amendment posted 10/17 adding 6 new study sites:
 
2 in Canada
3 in Chile
1 in Spain
 
Now multinational adding to 6 in Australia. All 12 are recruiting.
 
Still none in US I suspect the additional 100 participants added to the P2 trial in May '23 has not yet been filled. Gotta fill additional P2 before recruiting for P3. Only US sites in P2 restarted recruiting.
It's progress toward a point at which FDA believes P3 is sufficiently underway to accept an application for accelerated approval.


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Msg # Subject Author Recs Date Posted
18368 Phase 3 for lung cancer dar200 0 10/20/2023 11:40:19 AM




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