Long time holder here. Botanix had me at the acne treatment. SB is a pure bonus in my eyes.
There are 5 positives that I like the look of with FDA, making us very different to some of the comparables:So based on the above, I can see why the BOD is working 3 steps ahead of itself.
- First and most obvious: Positive results from Phase 3 clinical studies with both primary and secondary endpoints achieving statistical significance. As we know, the FDA places a heavy emphasis on Phase 3 data. Tick.
- Secondly, Safety Profile: One of the most crucial criteria for FDA approval is a favourable benefit-risk profile. No treatment-related serious adverse events and other adverse events were mild to moderate and transient. Tick.
- Third - Patient Need & Available Treatments: The FDA considers the current need for treatments in a given condition. Hyperhidrosis has a significant impact on patient's quality of life, and while treatments are available, there are still unmet needs in the space. Tick.
- Fourth - Method of Administration: The applicator design, which prevents direct hand contact with the drug, might be seen as a beneficial feature, especially if it reduces potential side effects or enhances patient compliance. Tick.
- Finally - Historical Precedence: Drugs with mechanisms of action similar to those previously approved by the FDA have a higher chance of approval. Anticholinergic drugs have been approved for various indications in the past. It's not always best to be the first cab off the rank. Tick.
DYOR.
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