Rant and the PR edited:
Some useful information, but again, poorly executed PR & CC. NP boasting and bullcrap on top of lack of organization and missing focus and the objective- which is to get this drug to market for COVID- today! For gods sake hire some competent marketing professionals to help you stay focused. Cost ya about $5-10k a month. Incompetent Marketing will kill- CYDY would have had a EUA months ago with a C-Level Marketing Director to create the laser focus on value creation on COVID. Most scientists just don't get that Brand Assets are worth more than patents or data.
CREATE A SENSE OF URGENCY! FOCUS!
NP cannot stay on his own script and forgets the point: The objective of this PR & this CC is to stimulate participation in and completion of this trial-ASAP! AND GET THE DRUG TO MARKET. It is not educate the public about DSMC minutia, or what your fuzzy timelines are or what your doing about anything other than COVID. COVID. COVID.... COVID.
Its telling a story that people are desperate to hear: a potential solution to COVID. Period. COVID. (Oh, oh, but what about NASH, NASDQ, XYZ? "Dr. Lazri/Dr. Kelly/Dr. XYZ will have a NASH/NASDQ/XYZ update on or before November X. Next question please.")
CREATE URGENCY: Write a headline and run a CC with news a media outlet can use verbatim:
Primary Headline: "Excellent COVID-19 Interim Analysis on Mortality Prevention Study for Novel Monoclonal Antibody Drug: Leronlimab."
Secondary Headline : "300,000 Doses of Monoclonal Antibody Leronlimab in Stock with 800,000 more to ship based on Phase 2b/3 trial results"
(Vancouver, WA) Cytodyn, Inc., a small biotech company, announced today excellent Interim Results Analysis recommendations by the Data Safety Monitoring Committee (DSMC) on their lead product Leronlimab, a monoclonal antibody. The interim analysis was performed on data from the first 195 (50%) of 390 planned patients in a Double Blind Phase 2b/3 clinical trial.
Safety and efficacy data led the DSMC to recommend the trial continue without modification to achieve the primary endpoint of mortality reduction. The DSMC also requests another interim analysis when enrollment reaches 75% level, as patient mortality and other clinical outcome data may be sufficiently positive to conclude the study early.
Enrolment for Severe and Critical COVID-19 patients is currently available in 14 hospitals throughout the USA. Patients in the UK will soon be able to participate in this study at seven hospitals.
To meet potential COVID-19 demand Cytodyn has 300,000 doses of Leronlimab in stock now. Over 800,000 more doses are on order and in process in anticipation of potential FDA Emergency Use Authorization. Cytodyn is seeking approval for Leronlimab for patients in these most dire of circumstances, people that are severely and critically ill such as on a ventilator, with multiple organ damage or septic shock.
COVID-19 mortality has reached 220,000 U.S. citizens and authorities project this to reach 400,000 deaths by year end without treatment. Given that that the CDC states vaccines will not be widely available until the middle of 2021 potential treatments like Leronlimab are urgently needed.
