From Redit Overview of breakthrough designation
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Posted On: 10/07/2025 7:00:01 AM
From Redit
Overview of breakthrough designation
To qualify for FDA Breakthrough Designation, applicants must submit early clinical evidence showing their drug or device offers a substantial improvement over existing therapies for a serious or life-threatening condition, with preliminary data demonstrating a significant benefit. For Drugs & Biologics Serious or Life-Threatening Condition: The drug must be intended to treat a serious or life-threatening disease or condition.
Preliminary Clinical Evidence: Early clinical evidence must demonstrate the drug may offer a substantial improvement over available therapy on at least one clinically significant endpoint. This could include improved survival, reduced disease progression, or superior symptom management. Unmet Medical Need: The drug must address a condition with limited or ineffective existing treatments, representing an unmet medical need. $sprb launched 1400% today on btd. That would put us at $14/share. Also look at the price history on it. $4 back in March 2025 but in 2020 it was $2k/share.
https://finance.yahoo.com/quote/SPRB/
Overview of breakthrough designation
To qualify for FDA Breakthrough Designation, applicants must submit early clinical evidence showing their drug or device offers a substantial improvement over existing therapies for a serious or life-threatening condition, with preliminary data demonstrating a significant benefit. For Drugs & Biologics Serious or Life-Threatening Condition: The drug must be intended to treat a serious or life-threatening disease or condition.
Preliminary Clinical Evidence: Early clinical evidence must demonstrate the drug may offer a substantial improvement over available therapy on at least one clinically significant endpoint. This could include improved survival, reduced disease progression, or superior symptom management. Unmet Medical Need: The drug must address a condition with limited or ineffective existing treatments, representing an unmet medical need. $sprb launched 1400% today on btd. That would put us at $14/share. Also look at the price history on it. $4 back in March 2025 but in 2020 it was $2k/share.
https://finance.yahoo.com/quote/SPRB/
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