1) Yes, it seemed like they issued conflicting PRs
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Posted On: 05/28/2019 10:38:49 AM
1) Yes, it seemed like they issued conflicting PRs on ODD. NP recently stated that they expected a response already and would follow-up with FDA after another 10 days or so (I believe this was noted at last weeks CC....so this may be our next PR?).I hope they keep TNBC separate, as they are close to injecting and setting up the MOA would take additional time.....plus with positive TNBC results, I would imagine recruiting would be easy. I may be missing something as many here are more familiar with these processes and what impact together vs. separate has?
2) No updates that I recall either and I understood the same for Colon IND. Although, IMO NP clearly hinted that the studies showed positive results....6:18-6:32 in this interview. https://www.proactiveinvestors.com/companies/...13376.html
3) No updates that I recall either.....although I would think they possibly used this data (in addition to the other 525 mg results from investigational trial) to help justify their pivotal IND for using 525 mg during the maintenance phase.
2) No updates that I recall either and I understood the same for Colon IND. Although, IMO NP clearly hinted that the studies showed positive results....6:18-6:32 in this interview. https://www.proactiveinvestors.com/companies/...13376.html
3) No updates that I recall either.....although I would think they possibly used this data (in addition to the other 525 mg results from investigational trial) to help justify their pivotal IND for using 525 mg during the maintenance phase.
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