Elmiron, page-21

I was initially worried about this pending lawsuit too and its potential implications for the approval of future PPS products. Since no approval = no future revenues = worthless shares.

"Of the 91 patients examined, 22 presented clear signs of drug toxicity. Additionally, observed toxicity rose with the amount of drug consumed. Investigators noted the rate of toxicity of those taking 500 to 1000 grams was 11% and that number jumped to 42% when patients were taking 1500 grams or more."

Assuming 6% bioavailability for Elmiron, 500-1000g is equivalent to a 30-60g injectable dose and 1500g is equivalent to 90g.

Maximum Zilosul dosage for a patient over 100kg is 200mg per injection. That's 2.4g for the 12 injections over the first year. I'm not sure what the prescribed annual top up dosage is, but let's say it's 2 injections annually from year 2 onwards. It would take 69 years for a patient to reach 30g and 219 years to reach 90g. Under a worst case scenario, a patient would therefore need to use Zilosul for 69 years to have a 11% chance of developing retinal maculopathy, and 219 years to have a 42% chance. Given the average onset of OA is around 50 years old, those timeframes are pretty irrelevant compared to the benefits.

This is of course still a pending lawsuit and the claims against Elmiron remain to the proven. My calculations also assume the worst case scenario of a 1 to 1 correlation between bioavailability and toxicity, which may not necessarily be the case. However, I'm not a scientist and it's still good to calculate what the absolute worst case scenario is.