THE LPAD PATHWAY.
On last week’s conference call to discuss the statistical significance of the unblinded Neutrolin Phase III data, Khoso and Chew provided shareholders with additional color regarding CRMD’s upcoming meeting with the FDA. CRMD will request their flagship drug, Neutrolin, be approved for hemodialysis patients under the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). CRMD is able to make the request based on two game-changing data driven events: (1) stellar DSMB Interim Safety Analysis Report; and (2) the highly statistically significant 72% reduction in the risk of CSRBIs over the current standard of care, Heparin.
THE LPAD PRECEDENT.
In September 2018, Arikayce (INSMED) was the first drug to receive approval under the FDA’s new LPAD regulatory approval process. The LPAD designation enabled INSMED to begin commercializing Arikayce in the United States less than two months after approval. Because Arikayce and Neutrolin share many of the same underlying characteristics, Chew believes Neutrolin to be a serious candidate for the coveted LPAD designation:
· Arikayce is a treatment for patients who had very limited options to combat a life-threatening bacteria-driven lung disease; Neutrolin is now a statistically proven treatment to combat life threatening CRBSIs.
· Arikayce LPAD approval was based on results from INSMED’s then-active Phase III CONVERT study, which met its primary endpoint…with statistical significance; Neutrolin Phase III trial—the largest body of evidence ever generated in hemodialysis patients using a catheter lock system—was halted on the DSMB recommendation and backed by highly statistically significant results.
· Arikayce has FDA Fast Track status and is designated as a Qualified Infectious Disease Product; Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product.
AFTER THE MEETING.
CRMD will update the market post-FDA meeting. The following are two outcomes I think possible (with Scenario #2 more likely):
· Scenario #1. The FDA gives CRMD the green light for the use of Neutrolin for hemo, oncology and ICU patients for commercialization. This year.
· Scenario #2. The FDA green lights CRMD’s commercialization of Neutrolin for hemo patients, but requires CRMD (as part of the condition of accelerated approval) to work with the FDA on an additional small scale clinical study (oncology or ICU) to support full approval across hemo, oncology and ICU. Such was the case with INSMED’s Arikayce.
OTHER FACTORS TO CONSIDER.
· Massive Insider buying last month.
· Elliot Associates, L.P. is elevated to activist Investor status by upping ownership by 60.9% from 4,744,036 shares to 7,633,466 shares.
· Vanguard Group added 1,000,000 shares.
· Gary Gelbfish relinquishes his seat on the Board. As for a potential replacement? "The Company has identified and is pursuing a number of qualified Board candidates with recognized applicable expertise in drug development and FDA interaction who have indicated they would be disposed to accept an invitation to join the Cormedix Board, with the goal of bringing this process to a successful conclusion in the near future.”
· All 10 January 2019 SEC filings related to RSU and Stock Option compensation for the Board of Directors (Gary Gelbfish, Janet Dillione, Myron Kaplan, Mehmood Khan Steven Lefkowitz, and even Khoso) include RSU & stock option grant language not seen in any previous year—a monthly vesting schedule: “These shares consist of RSUs (or Stock Options) granted on 01/10/2019. These restricted stock units will vest monthly with full vesting on the first anniversary of the date of grant, subject to continued service on the board.”
MY BASELESS, UNRELIABLE, AND HIGHLY OPINIONATED PREDICTION.
Six months ago, Cormedix delivered a shot across the bow to Big Pharma with the interest safety analysis report. Last week Cormedix fired a second. There won’t be a 3rd. Neutrolin is an unparalleled disruptor in a market space worth billions. It will be the Standard of Care within a very short period of time.
Big Pharma won’t compete with CRMD.
Big Pharma will buy CRMD or offer a staggering partnership.
And it will happen much sooner than people think.
