Rules are meant to be broken..
When it comes to life, nothing else matters. Not even rules and regulations. Those very rules and regulations we treat like God- don’t matter much. Rules are for peacetime; not when you are on war. FDA clear remdesivir as COVID-19 treatment reminds me of this fact.
Why FDA approval is so vital?
Companies from across the world seek approvals desperately from the US Food and Drug Administration (FDA) just to have a business opportunity in the US. Do you know why so much desperation? Why Pharmaceuticals are not happy in their own country? Why FDA approval is so vital?
Because- for these Pharmaceuticals companies, the FDA clearance is kind of an undocumented license to do their business in almost any uncharted land in the world. FDA means that divine and the ultimate frontier where the opportunities lie beyond it !!
But it is never easy and it takes hell lot of standardisation and toil to get that critical approval.
Why FDA cleared remdesivir as COVID-19 treatment?
China Virus turned out to be very lethal for this world. Such havoc the China virus Kovid-19 has created in the US that the Americans are desperate for help. They are bypassing those strict regularizations at this moment including FDA. The attack has so much severity that the FDA has issued emergency authorisation for the drug; remdesivir. Remdesivir is cleared to be used for COVID-19 where patients are hospitalised with a severe condition.
Not much is known about Remdesivir..
By the way, the FDA is honest though. The FDA has admitted that they have limited information about the safety or effectiveness of this experimental drug. They have recommended it just because it is more convincing from the rest of the candidates!!
Remdesivir, an experimental antiviral drug produced by biotech firm Gilead Sciences has shown a faster recovery time in some patients.
This clearance was given within just two days after the drug showed a “clear-cut positive effect” in a trial. In normal situations, the drug clearance comes in months and sometimes in years! Such is the state of the United State!
The terror this Corona has unleashed on all of us is unprecedented. The two-day clearance is given just because the trials show that remdesivir helps patients recover from the coronavirus faster. These trials involving 1,000 patients have shown a 31% faster recovery time, and a lesser mortality rate.
FDA cleared remdesivir for Gilead partners too?
Gilead, the manufacturer of the remdesivir has limited supply capabilities so they are approaching the Pharmaceuticals across the globe to increase the supply of remdesivir. The companies from the rest of the world have an opportunity here to prove a point.
So, as seen here, all the rules, regulations and procedures have gone for a toss, and the FDA is breaking its laws as shown here why FDA cleared remdesivir. I remember Arnold Schwarzenegger quoting once “Break the rules, not the law’’. Let us hope the remdesivir brings some smiles in this depressing time.