WHAT??? 4430 IV trial was already completed!!! | BCRX Message Board Posts

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Msg  11136 of 11281  at  2/13/2020 7:35:58 PM  by

rwehapi


 In response to msg 11128 by  map.here
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Re: WHAT??? 4430 IV trial was already completed!!!

Weird - you would think a straight answer would be easy enough. Here is link for a comparison of updates - it lists Marburg as the disease being tested. There is also one on the trials site listing Sao Paolo for the yellow fever testing.

https://clinicaltrials.gov/ct2/history/NCT03800173?A=1&B=2&C=Side-by-Side#StudyPageTop

Since no 7353 NDA PR, I think they might have got some sort of CRL for additional info. That would be nuts considering the fast track process should have been very iterative and transparent about what the NDA should contain...but I do see other CRL PR's from other firms that say they were totally surprised when issued a CRL with items never mentioned during fast track. So we shall see what happens after 72 days.


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Replies
Msg # Subject Author Recs Date Posted
11138 Re: WHAT??? 4430 IV trial was already completed!!! lysander_us 0 2/13/2020 8:03:14 PM
11139 Re: WHAT??? 4430 IV trial was already completed!!! mdaddy1234 0 2/13/2020 10:09:42 PM






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