Here it is...from Farrell90... Saturday, 12/15/
Post# of 72446
(Total Views: 347)
Posted On: 12/15/2018 9:10:26 PM
Here it is...from Farrell90...
Saturday, 12/15/18 06:21:29 PM
Re: frrol post# 251406 0
Post # of 251436
Good posts today. In the upcoming end of phase 2 meeting, I believe Brilacidin OM has an excellent chance for Breakthrough Therapy designation {BTD} due to the following:
1.The excellent safety profile demonstrated in the well done FDA stage 2 trial of intravenous Brilacidin for ABSSSI.
2. Simplicity of delivery [an oral swish]
3. Lack of other effective treatments
4. The seriousness of Oral Mucositis as a painful, debilitating, significant complication which impedes the delivery of effective treatment for Head and Neck cancer patients.
The FDA criteria for BTD
"Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)."
"A significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy"
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm
The BTD will be a signal to any potential pharmaceutical partners the FDA believes Brilacidin is a significant pharmaceutical and the FDA is committed to assist in its development.
FDA's potential assistance may include:
" All Fast Track designation features
Intensive guidance on an efficient drug development program
Organizational commitment involving senior managers"
"A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA."
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
The last paragraph could very well apply to Brilacidin OM.
IMO Brilacidin OM may soon meet the FDA criteria for Fast track designation which could open the path for early BLA and NDA.
Designations which would be very valuable to potential partners and could expedite development of Brilacidin OM.
JMO, Farrell
Saturday, 12/15/18 06:21:29 PM
Re: frrol post# 251406 0
Post # of 251436
Good posts today. In the upcoming end of phase 2 meeting, I believe Brilacidin OM has an excellent chance for Breakthrough Therapy designation {BTD} due to the following:
1.The excellent safety profile demonstrated in the well done FDA stage 2 trial of intravenous Brilacidin for ABSSSI.
2. Simplicity of delivery [an oral swish]
3. Lack of other effective treatments
4. The seriousness of Oral Mucositis as a painful, debilitating, significant complication which impedes the delivery of effective treatment for Head and Neck cancer patients.
The FDA criteria for BTD
"Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)."
"A significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy"
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm
The BTD will be a signal to any potential pharmaceutical partners the FDA believes Brilacidin is a significant pharmaceutical and the FDA is committed to assist in its development.
FDA's potential assistance may include:
" All Fast Track designation features
Intensive guidance on an efficient drug development program
Organizational commitment involving senior managers"
"A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA."
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
The last paragraph could very well apply to Brilacidin OM.
IMO Brilacidin OM may soon meet the FDA criteria for Fast track designation which could open the path for early BLA and NDA.
Designations which would be very valuable to potential partners and could expedite development of Brilacidin OM.
JMO, Farrell
(2)
(0)