This is my favorite part of the FDA denial of BTD for Aviptadil:
"NRx will comply with FDA’s instruction and will additionally augment its new BTD application with the recently-posted NIH guidelines that identify no benefit associated with the use of remdesivir in the categories of patients represented in NRx’s trial"
Let me translate that for you all.
"NRx hears what the FDA is saying and here's what we're going to do. First, we will resubmit our BTD application BUT this time we're going to also add a part about how the FDA was stupid in granting Remdesivir an approval..."
Here's why that may not be a great strategy:
"In denying BTD, the FDA noted that NRx did not distinguish the effects of ZYESAMI from the reported effects of remdesivir in critically-ill patients."
As we all know, one of the strongest retorts to "your product didn't do anything Remdesivir isn't already doing" would be to respond to the FDA with evidence Remdesivir doesn't work at all. Ipso Facto Aviptadil doesn't work either. Brilliant!
I'd be lying if I didn't say I enjoy seeing RLFTF languish around .05, but only because many of their investors chose to rag on CYDY along the way. Which brings me to a point that I think is worth noting.
Lately I've seen some of the bashers trying to claim that since there are other drugs which may get to market before CYDY for Nash that it's a dead end.
To that I'd ask why anyone bothered to bring blood pressure drugs to market after diuretics were introduced in the 50's then? Because there have been a ton of successful and very profitable drugs to come along.
Beta-blockers
ACE inhibitors
Angiotensin II receptor blockers
Calcium channel blockers
Alpha blockers
Alpha-2 Receptor Agonists
Combined alpha and beta-blockers
Central agonists
Peripheral adrenergic inhibitors
Vasodilators
There is an advantage to coming (pun developing) to market first though. Take Viagra, for instance (pun completed) and what happened once Cialis and Levitra debuted. Because while Viagra was first, it wasn't definitively the best. Cialis gave you a larger (lazy pun) window of activity and Levitra was more potent (and possibly slightly more effective) with less side effects. All made quite a bit of money for their respective companies.
Arguing that stopping the trials because there may end up being another company's drug that debuts first is laughable.
Another laughable thing? This unbelievable run-on sentence from our friends at Pomerantz Law Firm. Apparently Ess Tech, a company I follow but am not invested in, drew their ire for having to redo a portion of their books. Look at this beautifully ridiculous single sentence from their PR:
"On November 22, 2021, in a filing with the U.S. Securities and Exchange Commission, ESS Tech disclosed that “[o]n November 22, 2021, the Company’s management and the Audit Committee of the Board of Directors of the Company (the “Audit Committee”), after consultation with Marcum, concluded that STWO’s previously issued (i) audited balance sheet as of September 21, 2020, as previously restated, as reported in the Current Report on Form 8-K filed on September 25, 2020, (ii) audited financial statements as of December 31, 2020, and for the period from July 21, 2020 (inception) to December 31, 2020, as previously restated, as reported in the Annual Report on Form 10-K/A filed on May 24, 2021, (iii) unaudited interim financial statements as of September 30, 2020, and for the period from July 21, 2020 (inception) through September 30, 2020 as previously restated, as reported in Quarterly Report on Form 10-Q filed on November 16, 2020, (iv) unaudited interim financial statements as of March 31, 2021, and for the period from January 1, 2021 through March 31, 2021, as reported in Quarterly Report on Form 10-Q filed on May 24, 2021, and (v) unaudited interim financial statements as of June 30, 2021, and for the period from April 1, 2021 through June 30, 2021, as reported in Quarterly Report on Form 10-Q filed on May 24, 2021, (the “Affected Period”) should no longer be relied upon and should be restated to report Class A Ordinary Shares as liabilities, restate the statement of changes in shareholders’ equity and restate EPS to allocate income and losses pro rata between the two classes of shares outstanding."
In their PR, Pomerantz is extremely proud of themselves:
"Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions."
Doesn't seem like something to be proud of to me. Maybe they also do some legit cases, but it sure seems that they're basically the ambulance chasers of the industry. Just an office full of 13d-types pouring over every press release and 10k hoping to find a missing period to build a case around.
Speaking of missed periods, I'm pregnant.
(With a little bundle of CYDY shares that I plan on carrying to full term)
It's hard (way too late non-qualifying Viagra pun) to know whether we're in our first, second, or third trimester. But we're definitely underway. Every time I think I know exactly where we are in the process I end up having to recalculate. However, in the next 9 months we should see the birth of our baby. And while it could technically happen in the next 3 months, I see it more likely occurring in the six to nine month timeframe.
But once that baby is pooped out (I'm no doctor, but I'm pretty sure that's how it works and I'll be taking no questions) there'll be no turning back. Little Leron is going to grow into an absolute beast.
"NRx will comply with FDA’s instruction and will additionally augment its new BTD application with the recently-posted NIH guidelines that identify no benefit associated with the use of remdesivir in the categories of patients represented in NRx’s trial"
Let me translate that for you all.
"NRx hears what the FDA is saying and here's what we're going to do. First, we will resubmit our BTD application BUT this time we're going to also add a part about how the FDA was stupid in granting Remdesivir an approval..."
Here's why that may not be a great strategy:
"In denying BTD, the FDA noted that NRx did not distinguish the effects of ZYESAMI from the reported effects of remdesivir in critically-ill patients."
As we all know, one of the strongest retorts to "your product didn't do anything Remdesivir isn't already doing" would be to respond to the FDA with evidence Remdesivir doesn't work at all. Ipso Facto Aviptadil doesn't work either. Brilliant!
I'd be lying if I didn't say I enjoy seeing RLFTF languish around .05, but only because many of their investors chose to rag on CYDY along the way. Which brings me to a point that I think is worth noting.
Lately I've seen some of the bashers trying to claim that since there are other drugs which may get to market before CYDY for Nash that it's a dead end.
To that I'd ask why anyone bothered to bring blood pressure drugs to market after diuretics were introduced in the 50's then? Because there have been a ton of successful and very profitable drugs to come along.
Beta-blockers
ACE inhibitors
Angiotensin II receptor blockers
Calcium channel blockers
Alpha blockers
Alpha-2 Receptor Agonists
Combined alpha and beta-blockers
Central agonists
Peripheral adrenergic inhibitors
Vasodilators
There is an advantage to coming (pun developing) to market first though. Take Viagra, for instance (pun completed) and what happened once Cialis and Levitra debuted. Because while Viagra was first, it wasn't definitively the best. Cialis gave you a larger (lazy pun) window of activity and Levitra was more potent (and possibly slightly more effective) with less side effects. All made quite a bit of money for their respective companies.
Arguing that stopping the trials because there may end up being another company's drug that debuts first is laughable.
Another laughable thing? This unbelievable run-on sentence from our friends at Pomerantz Law Firm. Apparently Ess Tech, a company I follow but am not invested in, drew their ire for having to redo a portion of their books. Look at this beautifully ridiculous single sentence from their PR:
"On November 22, 2021, in a filing with the U.S. Securities and Exchange Commission, ESS Tech disclosed that “[o]n November 22, 2021, the Company’s management and the Audit Committee of the Board of Directors of the Company (the “Audit Committee”), after consultation with Marcum, concluded that STWO’s previously issued (i) audited balance sheet as of September 21, 2020, as previously restated, as reported in the Current Report on Form 8-K filed on September 25, 2020, (ii) audited financial statements as of December 31, 2020, and for the period from July 21, 2020 (inception) to December 31, 2020, as previously restated, as reported in the Annual Report on Form 10-K/A filed on May 24, 2021, (iii) unaudited interim financial statements as of September 30, 2020, and for the period from July 21, 2020 (inception) through September 30, 2020 as previously restated, as reported in Quarterly Report on Form 10-Q filed on November 16, 2020, (iv) unaudited interim financial statements as of March 31, 2021, and for the period from January 1, 2021 through March 31, 2021, as reported in Quarterly Report on Form 10-Q filed on May 24, 2021, and (v) unaudited interim financial statements as of June 30, 2021, and for the period from April 1, 2021 through June 30, 2021, as reported in Quarterly Report on Form 10-Q filed on May 24, 2021, (the “Affected Period”) should no longer be relied upon and should be restated to report Class A Ordinary Shares as liabilities, restate the statement of changes in shareholders’ equity and restate EPS to allocate income and losses pro rata between the two classes of shares outstanding."
In their PR, Pomerantz is extremely proud of themselves:
"Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions."
Doesn't seem like something to be proud of to me. Maybe they also do some legit cases, but it sure seems that they're basically the ambulance chasers of the industry. Just an office full of 13d-types pouring over every press release and 10k hoping to find a missing period to build a case around.
Speaking of missed periods, I'm pregnant.
(With a little bundle of CYDY shares that I plan on carrying to full term)
It's hard (way too late non-qualifying Viagra pun) to know whether we're in our first, second, or third trimester. But we're definitely underway. Every time I think I know exactly where we are in the process I end up having to recalculate. However, in the next 9 months we should see the birth of our baby. And while it could technically happen in the next 3 months, I see it more likely occurring in the six to nine month timeframe.
But once that baby is pooped out (I'm no doctor, but I'm pretty sure that's how it works and I'll be taking no questions) there'll be no turning back. Little Leron is going to grow into an absolute beast.
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