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Posted On: 05/16/2024 9:32:03 PM
Post# of 148870
I think this is another good reason as to why CRC.
Before people start reading I’ll save you some time if you don’t want to read much further. It appears that with CRC we are trying to get accelerated approval. Makes sense I was wondering why states approval in this indication. No phase 3? Maybe? Maybe not?
FAQ Section Below From the website.
“What clinical trials is the Company currently working on?
In order of priority, the clinical trials currently under development are:
(i) a Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer; and
(ii) a Phase II study exploring leronlimab and its effects on inflammation.
The oncology trial, if successful, will put the Company on track towards a commercial approval in that indication. The inflammation study is aimed at clarifying a number of past clinical observations as it relates to leronlimab.”
No guarantees but I’m betting they are aiming for approval after the trial.
I posed the question to AI. Due to the wording of the website looks like we won’t be needing a phase 3 trial if this works out in our favor.
“Yes, it is possible to get special approval for a drug after a Phase 2 trial without completing a Phase 3 trial, but this is relatively rare and typically occurs under specific circumstances. Here are some of the pathways and conditions under which this can happen:
1. Accelerated Approval
- **Criteria**: This pathway allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint that is reasonably likely to predict clinical benefit.
- **Conditions**: The drug must show promising results in Phase 2 trials, such as significant improvement in biomarkers or other surrogate endpoints.
2. Breakthrough Therapy Designation
- **Criteria**: This designation is given to drugs that show substantial improvement over existing therapies on one or more clinically significant endpoints.
- **Conditions**: With this designation, the FDA provides intensive guidance on the development program and can expedite the review process. This can sometimes lead to approval after Phase 2 if the results are compelling enough.
3. Emergency Use Authorization (EUA)
- **Criteria**: This is used during public health emergencies to allow the use of unapproved medical products or unapproved uses of approved products.
- **Conditions**: The drug must show sufficient evidence of safety and efficacy to address the emergency situation. This is typically seen with vaccines or treatments for outbreaks like COVID-19.
4. Conditional Approval (Europe)
- **Criteria**: Similar to accelerated approval in the US, the European Medicines Agency (EMA) can grant conditional marketing authorization for medicines that address unmet medical needs.
- **Conditions**: The authorization is based on less comprehensive data than normally required, with the understanding that the company will provide additional data post-approval.
5. Compassionate Use/Expanded Access
- **Criteria**: Patients with serious or life-threatening conditions who cannot participate in a clinical trial may be allowed access to experimental drugs.
- **Conditions**: This is not an approval but allows broader use of the drug while trials are ongoing.
Examples
- **Pembrolizumab (Keytruda)**: Received accelerated approval for certain cancers based on early clinical data showing substantial benefit.
- **Remdesivir**: Received EUA during the COVID-19 pandemic after showing promise in early trials.
Conclusion
While it is possible to receive special approval for a drug after a Phase 2 trial, it requires compelling evidence that the drug is safe and effective for treating serious conditions with unmet medical needs. Regulatory agencies like the FDA and EMA have specific pathways to expedite the approval process under these circumstances.
Maybe we have a good shot of not having to complete a phase 3?
I want to see these manuscripts!
Before people start reading I’ll save you some time if you don’t want to read much further. It appears that with CRC we are trying to get accelerated approval. Makes sense I was wondering why states approval in this indication. No phase 3? Maybe? Maybe not?
FAQ Section Below From the website.
“What clinical trials is the Company currently working on?
In order of priority, the clinical trials currently under development are:
(i) a Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer; and
(ii) a Phase II study exploring leronlimab and its effects on inflammation.
The oncology trial, if successful, will put the Company on track towards a commercial approval in that indication. The inflammation study is aimed at clarifying a number of past clinical observations as it relates to leronlimab.”
No guarantees but I’m betting they are aiming for approval after the trial.
I posed the question to AI. Due to the wording of the website looks like we won’t be needing a phase 3 trial if this works out in our favor.
“Yes, it is possible to get special approval for a drug after a Phase 2 trial without completing a Phase 3 trial, but this is relatively rare and typically occurs under specific circumstances. Here are some of the pathways and conditions under which this can happen:
1. Accelerated Approval
- **Criteria**: This pathway allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint that is reasonably likely to predict clinical benefit.
- **Conditions**: The drug must show promising results in Phase 2 trials, such as significant improvement in biomarkers or other surrogate endpoints.
2. Breakthrough Therapy Designation
- **Criteria**: This designation is given to drugs that show substantial improvement over existing therapies on one or more clinically significant endpoints.
- **Conditions**: With this designation, the FDA provides intensive guidance on the development program and can expedite the review process. This can sometimes lead to approval after Phase 2 if the results are compelling enough.
3. Emergency Use Authorization (EUA)
- **Criteria**: This is used during public health emergencies to allow the use of unapproved medical products or unapproved uses of approved products.
- **Conditions**: The drug must show sufficient evidence of safety and efficacy to address the emergency situation. This is typically seen with vaccines or treatments for outbreaks like COVID-19.
4. Conditional Approval (Europe)
- **Criteria**: Similar to accelerated approval in the US, the European Medicines Agency (EMA) can grant conditional marketing authorization for medicines that address unmet medical needs.
- **Conditions**: The authorization is based on less comprehensive data than normally required, with the understanding that the company will provide additional data post-approval.
5. Compassionate Use/Expanded Access
- **Criteria**: Patients with serious or life-threatening conditions who cannot participate in a clinical trial may be allowed access to experimental drugs.
- **Conditions**: This is not an approval but allows broader use of the drug while trials are ongoing.
Examples
- **Pembrolizumab (Keytruda)**: Received accelerated approval for certain cancers based on early clinical data showing substantial benefit.
- **Remdesivir**: Received EUA during the COVID-19 pandemic after showing promise in early trials.
Conclusion
While it is possible to receive special approval for a drug after a Phase 2 trial, it requires compelling evidence that the drug is safe and effective for treating serious conditions with unmet medical needs. Regulatory agencies like the FDA and EMA have specific pathways to expedite the approval process under these circumstances.
Maybe we have a good shot of not having to complete a phase 3?
I want to see these manuscripts!
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