Here's my favorite part of the PR. "The CSR is
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Posted On: 01/03/2018 7:05:12 PM
Here's my favorite part of the PR.
"The CSR is central for engaging with the FDA to further discuss program development, and is also an important component for informing already advanced OM partnership discussions ."
If IPIX can finish the CSR this month, I expect it'll take another 1-2 months for the BTD decision and 3-4 months to get a deal done. BTD is a lock IMO. Here are the requirements.
Requirement #1 - SOM is a serious / life-threatening disease. Check
Requirement #2 - Patients are ~50% less likely to develop SOM using B-OM. Existing therapies cannot prevent SOM. Substantial improvement? Check
"The CSR is central for engaging with the FDA to further discuss program development, and is also an important component for informing already advanced OM partnership discussions ."
If IPIX can finish the CSR this month, I expect it'll take another 1-2 months for the BTD decision and 3-4 months to get a deal done. BTD is a lock IMO. Here are the requirements.
Quote:
A breakthrough therapy is a drug:
- intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
- preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
https://www.fda.gov/RegulatoryInformation/Law...329491.htm
Requirement #1 - SOM is a serious / life-threatening disease. Check
Requirement #2 - Patients are ~50% less likely to develop SOM using B-OM. Existing therapies cannot prevent SOM. Substantial improvement? Check
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