CorMedix Inc (CRMD)

[Rapture2020]

Follow up #2--more musing and my opinion only about CRMD and the LPAD for hemodialysis patients...

CRMD’s request for the NDA pathway via LPAD will be limited in scope to include Neutrolin to hemodialysis patients with central venous catheters (LOCK-IT-100). While this is the smallest of CRMD's 3 verticals (Oncology/NPS & ICU are the other two), CRMD estimates a potential U.S. market of 660,000 patients (annually). This would require 31,000,000 units (annually). ANNUALLY.

If given the green light by the FDA in Q1 CY19, CMRD would need to be in a position to deliver millions of units next year. Does anyone think CRMD can do this with their existing R&D-based infrastructure (comprised of 19 employees)? I don't.

Only a handful of companies have been given LPAD designation since it rolled out earlier this year. What I am most interested in is the time delta between FDA green light and product to market. If it's a tight window, then it stands to reason they may already have a partner lined up. Why go to the FDA about a great product for LDAP designation, get approval, celebrate, and then realize the 19 people in your company don't have clue about how to get the product to market. It's not a goof on their existing talent base, just not in their immediate wheelhouse.

If that's the case, a partnership might very well be locked down.

Again, complete conjecture and speculation on my part. But I do draw comfort in knowing that the rabbit hole I dove into on Wednesday makes complete sense to me. And it truth, it may be just one of a dozen avenues being explored by the company.


Please, please please let the data be as constant as the Northern start upon unblinding.




http://www.cormedix.com/wp-content/uploads/2018/09/WainWright-Presentation-Sept-6th-2018-Final2-2.pdf