Need I say more. After applying to the USFDA under the Emergency Use Program I realized very quickly that I was not just going to give away my [IP] TO Big Corporate Pharmaceutical for the sake of argument this past March. But decided to act instead and do what I do best which after as much Due Diligence and research create another first. The Current Trump Administration Solicited for solutions.. I answered before he admitted taking the API/ which they treated like Cannabis under scrutiny. Go figure...
Abstract
A Novel formulation for an Existing API Hydroxychloroquine Sulphate to be aerosolized via a pMDI/Pressurized Metered Dose Inhaler as a Prophylactic Combination Medical delivery device for Oral and Inline Ventilator Care of COVID-19
It was a decision after considering most was out in the world being cited and recommended, and my obvious 1st choice to tackle the Novel SARs 2 Covid-19 virus before it was declared a Pandemic by The WHO.
In the beginning I began as extensive background research as I was once a Medical School Candidate with a Biochemistry/Biology/ background; Various Industrial research ,University research,and Registered and California Licensed and Board Registered Cardiopulmonary Therapist with a background as an Allergy and Immunology Specialist in the US Air Force who dealt with W.H.O and the CDC when it came to staying up to date for U.S. Air Force veterans and Family members as well as other U.S. Services and they would have to often travel abroad. Where I gained experience in various Plant based dilutions and formulations for varied conditions of Seasonal/ Perennial Allergy, as well as treatment protocols and Research in the early years of R.A.S.T./ Elisa research with physicians collaborating with others a Stanford University in Palo Alto Northern California from 1979-1982. I've remained tethered to Science my entire life.
Back Story
This was not SARs' Corona Virus newest (Jump Over) into humans. Many are quick to forget circa 2003. This [ Novel SARs2 CoVid-19] will not be the last..
Severe acute respiratory syndrome (SARS) appeared in 2002 and quickly spread around the world. The Centers for Disease Control (CDC) reported that 8,098 people were infected in 26 countries, and that 774 died. (Other sources report slightly different numbers.)
SARS was called the first pandemic of the 21st century. It would not be the last. Nor would it be the most deadly.
Since Chinese officials first reported the COVID-19 outbreak in Wuhan December 31, 2019, the virus has spread to 206 countries. By about 5 p.m. PST on April 1, Johns Hopkins University reported a steadily-climbing global infection rate of 719,669, with 42,075 deaths.
Phase (1) The obvious choice via deduction was Hydroxychloroquine Sulfate after review as this is Upper Airway then Lower Airway/ Pulmonary hostile takeover by this Positive Sense Single Strand RNA Virus/+SSSRNA. Extensive research of existing and Pre-existing of peer reviewed research that predated the 2003 Outbreak all the way back to basic and advanced science.
Phase (2) Correlation of all data relating to the API/HCQ-sulfate and its history and the scientific and empirical data as to why if should be used if I choose to do so. Regardless of the politicking and blatant attempts to tarnish its use.
Phase (3) Hypothesis:
Therapeutics: Drugs and/or drug/device combinations, or platforms currently under development demonstrating efficacy in post-exposure, pre- and post-symptomatic studies for any Covid strain, and capable of achieving EUA from the FDA within the next three (3) months for this ongoing SARS-CoV-2 pandemic. o Antibody technologies, accelerating the discovery, development, manufacturing, and prediction of success for these technologies, can also be considered. o Prophylactics: Drugs or vaccines currently under development demonstrating preexposure in vivo efficacy or in vitro activity against any or all strains of Covid. Antibody technology, accelerating the discovery, development, manufacturing and prediction of success for these technologies can be considered. o Clinical Trials: Opportunities to expeditiously conduct clinical trials for any technology that will require evaluation for FDA approval, will be considered.
Phase (4) Acquisition of the API, Materials and Method and (1st) Formulation. to using cGMP to infuse what is considered an Combination Medical Device by the FDA granted
medical device Emergency Use Authorizations related to Coronavirus Disease 2019 (COVID-19).
Phase (5) Doing much like what I had done in creating the Worlds First Medical pMDI/ propellant driven Cannabis Inhalers circa 2014. On July 4th 2020 after watching those who don't know Jack about science jockey like puppets and watching the numbers of deaths and illness climb throughout the world and here in Los Angeles California. I decided to act..ergo another first
Aerosol based Hydroxychloroquine Sulfate pMDI/ medical gas or pressurized Metered Dose Inhaler capable of delivered a micro-dose of a tried and tested API.
All precautions considered especially since I have the genetic condition of known as G6PD *
( Citations) later showing no evidence of HCQ exacerbating.
Also to date no reports what so ever of Mild/Moderate/or Severe hospitalized cases developing Tosades de Pointes as the causative factor of morbidity.**