possible to get topical pirenzepine for PN prior to FDA approval?

WinSanTor is developing a topical version of pirenzepine that in Phase I and II trials looks quite promising, not only for pain but for some possible nerve regeneration, as well. I received this communications from the company yesterday:

With nearly 40 million Americans affected by peripheral neuropathy, the need for effective treatments has never been more urgent. At WinSanTor, we are dedicated to bringing relief to those suffering from this debilitating condition, and we are thrilled to offer compassionate use access to our promising drug, WST-057. We are close to launching the program.

But here's the challenge: We have 2,000 spots available, yet only a little over 100 people have signed up. If peripheral neuropathy is affecting so many lives, we should have far more people expressing interest. This low registration doesn't reflect the true demand for new treatments, and without enough participants, we cannot move forward with the program.

This is a critical moment. We need to demonstrate that there is not only a need for a solution but also a demand for it. WinSanTor has tried everything to show there is a demand. Now it's your turn. By registering, you send a powerful message that those living with peripheral neuropathy are eager for better treatment options.

What can you do?
Register Today: If you're interested in compassionate use (of WST-057), sign up now to be considered.
Financial concerns?: We understand your concerns. We are working on a payment plan. Unfortunately, WinSanTor has limited resources and providing WST-057 at our cost (audited per FDA requirements)
Spread the Word: Encourage others in your network who are affected to register. Every registration brings us one step closer to launching this program.
Show Demand: We need several thousand people on our list before we can proceed. Your registration isn't just about access—it's about showing the world that peripheral neuropathy patients need better solutions.
Donate: WinSanTor has committed to setting aside resources for the Expanded Access Program. now we need your help.

If you are interested in participating in the Expanded Access Program, PLEASE FILL OUT THE REGISTRATION FORM.

Go to the WinSanTor website for more details and to obtain the application form if interested. If you want to get into the compassionate use program, allowed by the FDA, you will need a doctor referral/contact/diagnosis, and the cost of the drug without financial assistance is about $1900 for the six month trial, as I understand it.