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go_wamu

03/01/21 6:16 PM

#36674 RE: pegs1 #36673

The FDA doesn't care about sick people who urgently need new drugs. What do you actually imagine to make such demands?
Sarcasm off !!!

Bartsdad

03/01/21 6:59 PM

#36677 RE: pegs1 #36673

Pegs sound horrible I hope you can get it soon.

changes_iv

03/01/21 8:57 PM

#36680 RE: pegs1 #36673

Ms. Pegs1, thank you for your candid answers! I hope soon enough you’ll be able to have Zyesami(TM) IV first and if at all possible, the inhaled Zyesami (TM) afterwards. I agree, I believe Zyesami (TM) will be more powerful than the compounded drug. Best to you!

https://respiratory-research.biomedcentral.com/articles/10.1186/1465-9921-12-45

changes_iv

03/04/21 12:08 PM

#36789 RE: pegs1 #36673

Ms. Pegs1,

Did you ever feel under threat by any FDA arbitrary actions that would have impeded access to your VIP compound drug???

VIP was first used in CIRS patients in November, 2008. Its use has revolutionized care of CIRS in that not only does VIP correct symptoms and proteomics seen in affected patients, but it also corrects gray matter nuclear atrophy (think of early Alzheimer’s!) and the transcriptomic (gene activation and suppression) abnormalities that are the ultimate source of this illness. Without VIP, patients will be forced to either suffer needlessly (this illness can kill people too) or search for another neuroregulatory peptide that can safely reproduce the extraordinary benefits of VIP.

https://www.survivingmold.com/save-vip/vip-faces-removal-from-fda-compounding-list

The FDA wanted a multi-million dollar IND track for the compounded drug, yes??? Finally, VIP is in a multi-million IND track!!

They said aviptadil is shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes while also preventing synthesis of cytokines in the lung. It is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide, VIP), which has been granted FDA fast track designation, FDA emergency use IND authorisation, and an expanded access protocol.

https://www.reuters.com/article/us-health-coronavirus-relief-hldg-idINKCN2520ED
As soon as Zyesami (TM) gets approved, it is my understanding you will go for the Zyesami (TM) IV drug, yes??? If at all possible, you will follow the IV drug with the inhaled Zyesami (TM), yes??? I’m sure your lung specialist will be on top of this.

“We started off giving it [aviptadil] to the people who were critically ill with COVID-19—people who were on ventilators, high-flow oxygen. And we are now just starting studies where it will be given in an inhaled form for people who are less sick,” NeuroRx CEO and Chairman Jonathan Javitt, MD, MPH, told Contagion. “Most pulmonary drugs are best given in inhaled form but once someone has COVID distress and is on a ventilator there is a lot of debris in the lungs and reasons to give it intravenously.”

https://www.contagionlive.com/view/showing-promising-recovery-results-from-respiratory-failure-in-covid-19-patients