Edit: Just saw that BooDog posted basically the s
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(Total Views: 490)
Posted On: 09/11/2019 12:48:57 PM
Re: bettingbig #59865
Edit: Just saw that BooDog posted basically the same thoughts as below while I was writing this post.
Below is copied from the updated company overview on their website:
Oral Mucositis- PositivePh2 trial (reduced incidence and delayed onset of Severe Oral Mucositis)Completed End-of -Phase 2 meeting with FDA and aligned on Phase 3 Development program
I take it "aligned" means IPIX and FDA are on the same page regarding what needs to be done to proceed with a P3 trial. Still need the EMA input so that the P3 trial satisfies both FDA/EMA requirements.
Have to believe IPIX knows the EMA requirements by now (I personally do not see them varying by much, if any, from FDA requirements) and are working on how they want to proceed as to whether they will do this trial alone or franchise out the indication prior to P3, etc.
Would expect to get some guidance from mgt on future development regarding the P3 in the very near future.
Below is copied from the updated company overview on their website:
Oral Mucositis- PositivePh2 trial (reduced incidence and delayed onset of Severe Oral Mucositis)Completed End-of -Phase 2 meeting with FDA and aligned on Phase 3 Development program
I take it "aligned" means IPIX and FDA are on the same page regarding what needs to be done to proceed with a P3 trial. Still need the EMA input so that the P3 trial satisfies both FDA/EMA requirements.
Have to believe IPIX knows the EMA requirements by now (I personally do not see them varying by much, if any, from FDA requirements) and are working on how they want to proceed as to whether they will do this trial alone or franchise out the indication prior to P3, etc.
Would expect to get some guidance from mgt on future development regarding the P3 in the very near future.
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