Long time holder here. Botanix had me at the acne treatment. SB...

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:

• 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.

So based on the above, I can see why the BOD is working 3 steps ahead of itself.
DYOR.