Sunday, October 18, 2020 5:19:50 PM
"A Phase II Multicenter, Randomized, Double Blinded, Placebo Trial to Evaluate the Efficacy and Safety of Intramuscular Injections of ZofinTM Comparing with Intravenous Infusions for the Treatment of Post COVID-19 Complications and Severe Sequelae vs Placebo. IND submitted on 09/28/2020. Pending IND and IRB approval."
What!#?$?...They applied for a pure phase 2 trial utilizing intramuscular injection targeting long haulers. That is huge! Currently Zofin is delivered via an IV. The downside being an IV is a pure inpatient scenario. The patient must be checked into hospital and spend several hours laying on a cot hooked up to an IV. It's an expensive and time consuming process.
Contrast that to an Intramuscular Injection. The patient can visit any outpatient clinic where a tech can perform the procedure in a few minutes. Where subsequent doses could be applied at home with training. Its far more cost effective, fast and efficient. Everyone wins in this scenario doctors, hospital, patient, accountants etc...But more importantly, this is exactly the type of solution the FDA is looking for!
This is going to move the needle a bit when it gets approved which may be dependent on the results of our current trial? Or possibly a few more positive eIND results? Either way good things coming. GLTA.
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