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Posted On: 04/23/2019 8:37:35 PM
Post# of 72441
One of the latest false narratives by the bashers claim that the only way a Phase II trial can be described as a “huge success” is if it has been granted Breakthrough Technology Designation (BTD). Drano stated the following in one of his recent posts:
“But in the meantime, I prefer to look at actual relevant facts, not bogus comparisons.
• Brilacidin-OM was a huge success in the Phase 2 clinical trial.
• There is no currently approved treatment for Oral Mucositis.
• Brilacidin-OM is easy to administer.
• Brilacidin-OM has NO systemic absorption and no side effects that could interfere with the patient's ability to continue cancer treatment.
• Because there is no systemic absorption there are no concerns that it could interact with chemo drugs and make them less effective.
From the IPIX website: Innovation is evaluating Brilacidin, under Fast Track designation, in a Phase 2 clinical trial as an oral rinse to attenuate Oral Mucositis in patients with Head and Neck Cancer who have received chemoradiation. Topline study results indicate Brilacidin has a high potential for preventative treatment, as evidenced by a clear reduction of Severe OM (SOM) among patients on Brilacidin as compared to those on placebo. Additional secondary endpoint analysis, showing Brilacidin delayed the onset as well as reduced the duration of SOM, supports the drug candidate's therapeutic effect. The Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting. Both parties agreed to an acceptable Brilacidin Phase 3 development pathway.
So my question is that if IPIX gets a license partnership this coming week for $50-$100M upfront can we call it a “huge success” at that time or do we need to wait for BTD? Note that Brilacidin has already been granted Fast Track Designation that provides:
A fast track eligible drug must show some advantage over available treatment, such as:
• Showing superior effectiveness
• Avoiding serious side effects of an available treatment
• Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
• Decreasing a clinically significant toxicity of an available treatment
• Addressing an expected public health need.
A drug that receives Fast Track designation is eligible for some or all of the following:[3]
• 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 correspondence from FDA about such things as the design of the proposed clinical trials
• Accelerated Approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations.
• Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
My guess is that a partnership agreement will include additional milestone payments if BTD is awarded at some point. Attaining BTD would be further validation for the Brilacidin franchise and may be of value for indications other than B-OM but it is not a requirement to make the claim that Brilacidin is a huge success.
If I remember correctly one of the soft bashers claimed to have many years of experience working in the pharmaceutical industry so I am assuming that he must be well aware of all of the above information. One of his posts did state “A little late but apparently there must be benefits during P3.”
I realize I must be a big disappointment as well as I am not one of the many “subscribers” to the “Pro-rated bullshit”.
“But in the meantime, I prefer to look at actual relevant facts, not bogus comparisons.
• Brilacidin-OM was a huge success in the Phase 2 clinical trial.
• There is no currently approved treatment for Oral Mucositis.
• Brilacidin-OM is easy to administer.
• Brilacidin-OM has NO systemic absorption and no side effects that could interfere with the patient's ability to continue cancer treatment.
• Because there is no systemic absorption there are no concerns that it could interact with chemo drugs and make them less effective.
From the IPIX website: Innovation is evaluating Brilacidin, under Fast Track designation, in a Phase 2 clinical trial as an oral rinse to attenuate Oral Mucositis in patients with Head and Neck Cancer who have received chemoradiation. Topline study results indicate Brilacidin has a high potential for preventative treatment, as evidenced by a clear reduction of Severe OM (SOM) among patients on Brilacidin as compared to those on placebo. Additional secondary endpoint analysis, showing Brilacidin delayed the onset as well as reduced the duration of SOM, supports the drug candidate's therapeutic effect. The Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting. Both parties agreed to an acceptable Brilacidin Phase 3 development pathway.
So my question is that if IPIX gets a license partnership this coming week for $50-$100M upfront can we call it a “huge success” at that time or do we need to wait for BTD? Note that Brilacidin has already been granted Fast Track Designation that provides:
A fast track eligible drug must show some advantage over available treatment, such as:
• Showing superior effectiveness
• Avoiding serious side effects of an available treatment
• Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
• Decreasing a clinically significant toxicity of an available treatment
• Addressing an expected public health need.
A drug that receives Fast Track designation is eligible for some or all of the following:[3]
• 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 correspondence from FDA about such things as the design of the proposed clinical trials
• Accelerated Approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations.
• Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
My guess is that a partnership agreement will include additional milestone payments if BTD is awarded at some point. Attaining BTD would be further validation for the Brilacidin franchise and may be of value for indications other than B-OM but it is not a requirement to make the claim that Brilacidin is a huge success.
If I remember correctly one of the soft bashers claimed to have many years of experience working in the pharmaceutical industry so I am assuming that he must be well aware of all of the above information. One of his posts did state “A little late but apparently there must be benefits during P3.”
I realize I must be a big disappointment as well as I am not one of the many “subscribers” to the “Pro-rated bullshit”.
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