Clinical trials to FDA standards are very expensive. If an IND is in the works then QNTA management is preparing to sell shares to raise money for the trials. This is possibly the reason for change AS.
Ah...NOT necessarily - they can skin this cat many a different way :)
Their BIG MARKET opportunity is OUTSIDE N. American borders - aka The Dominican where they're really based out of, and then all of Latin America and even a fraction of Asia (Asia LOVES alternative treatments - and Scorpion Venom will be Tiger's Blood on steroids) and then Eastern Europe and that's a BILLION people right there to the USA paltry 340 mil population of men, women and children !
Merely passing the FDA IND gauntlet = a GOLD APPROVAL for example in The Dominican.
They'd be fast tracked right there and if they get Dominican approval then by default ALL of Latin America is wide, wide open - and they can sell $20 million of this stuff w/o even trying hard = NASDAQ company from that alone.
Toss in Asia - and it's $50 mil in sales w/o breaking a sweat if they get this to $100 to $200 a bottle price point and a serious marketing and branding campaign, and also an "in" with MD's in those nations who unlike the FDA heavy hand here - can "prescribe" almost anything they want once it's "registered" which is a 1,000X easier than FDA "APPROVAL"
Lastly- they get the IND FDA "signed off" and then LET PARTNERS run the clinical trial research and fund it - that is the new game way of doing things.
They're NOT after a "FULLY APPROVED FDA DRUG" - and never stated they were !
And FDA IND = compassionate use inside the USA and also clinical trial use for which they can then supply the product and work deals for rights to the data = prestige off-shore, etc.
AND - possibly an EMERGENCY USE designation for COVID, if not in the USA for sure in the Dominican IF the FDA grants IND status as the gold standard.
It's Wiiiiiiiide open here - and they're playing a much bigger game of chess than the tiny USA market and the complex bullshit "GET A DRUG FDA APPROVED" - as they DO NOT NEED THAT to easily hit $100 million annual sales OUTSIDE THE USA which is really where their prime market is !
CANCER TREATMENTS of the "alternative variety" are HUGE HUGE HUGE outside of the USA borders- and I mean mega huge and they know this and there's a reason LATIN AMERICA in in their sight and scope FIRST :)