Interesting post below from someone at the swamp..
Post# of 72440
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Posted On: 12/11/2017 11:37:39 AM
Interesting post below from someone at the swamp...I have always thought that a partnership was needed to make the SP reach appropriate levels.....
Got these answers back from Leo this morning: (his replys bolded by me)
Yes looking forward to duration results,..
- Will you still apply for Breakthrough Therapy Designation,..? Of Course.
- Will you try to increase doage or frequency of dosage,..? Why would I want to do this? I would believe the FDA would be encouraging us to move forward towards approval with these results.
I see the results good enough to do a deal with BP,.. we will be praying hard that you can do this!! We are waiting now for secondary study endpoints.
Also from Leo:
We believe the results are strong for this endpoint of prevention of SOM. Regarding the marketing of this drug (after all clinical trials are completed), If you break it down to common sense, a patient being treated has a 60 to 75% chance of having severe OM, a very painful disease, described as worse than the cancer pain, however if you take Brilacidin per protocol the odds are 36.8% I cant see a physician not prescribing the drug
and a patient not taking the drug. In addition we are awaiting secondary endpoint data which pertain to duration if one did get SOM.
Got these answers back from Leo this morning: (his replys bolded by me)
Yes looking forward to duration results,..
- Will you still apply for Breakthrough Therapy Designation,..? Of Course.
- Will you try to increase doage or frequency of dosage,..? Why would I want to do this? I would believe the FDA would be encouraging us to move forward towards approval with these results.
I see the results good enough to do a deal with BP,.. we will be praying hard that you can do this!! We are waiting now for secondary study endpoints.
Also from Leo:
We believe the results are strong for this endpoint of prevention of SOM. Regarding the marketing of this drug (after all clinical trials are completed), If you break it down to common sense, a patient being treated has a 60 to 75% chance of having severe OM, a very painful disease, described as worse than the cancer pain, however if you take Brilacidin per protocol the odds are 36.8% I cant see a physician not prescribing the drug
and a patient not taking the drug. In addition we are awaiting secondary endpoint data which pertain to duration if one did get SOM.
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