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Blue Fin

07/13/20 11:56 AM

#310846 RE: Barron4664 #310802

Barron 4664, This is what you are suggesting Leo is going for?

"Under the emergency declaration, IPIX only needs to have an approved application for investigational new drug in order to designate Brilicidan as a “covered countermeasure”.

THIS SHOULD BE STICKEYED:

IPIX will advance brilicidan for covid-19 under the declaration of national emergency. For the education of the posters here regarding how the gov works during a National Emergency please look up and read the following laws: National Emergency Act, Stafford Act ammendments of 2000, and 2006, and Project Bioshield Act PREP act. Together these four laws will guide the development of brilicidan for COVID-19. The PREP act is particularly important because its purpose is to make any action involving a “medical countermeasure” immune from any liability of federal or state law. Project Bioshield Act creates the concepts of a “medical countermeasure.” Here is a link to the PREP declaration posted to the Federal Register March 10:

https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx

Under the emergency declaration, IPIX only needs to have an approved application for investigational new drug in order to designate Brilicidan as a “covered countermeasure”. If B gets this designation then it can be prescribed as the gov sees fit to as many people as they want with no threat of any liability. In fact any injuries due to brilicidan would be covered by a fund established by the gov under the law (same as for vaccines). IPIX does not have to follow the normal sequence of events in order to get this drug into as many patients as possible. They only need to have the approved investigational new drug application to begin the process. Please read the executive order I linked then go re-read todays PR. Educate yourself with the law that is currently in effect.
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Lemoncat

07/13/20 12:50 PM

#310880 RE: Barron4664 #310802

I think the process will be very standard until results from the phase 2 come back.

Standard financing.
Standard timelines.

Once we get the phase 2 result back (and Gilead has made some money on Remdesivir), if COVID is still raging they may start giving us some help with the process.

It's sad that we have to go it alone and by the rules when every lobbying pharma is granted fast tracks and billions of dollars for their crap solutions.

We'll get there but we'll have to earn every foot of ground we take.

Go IPIX!
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DaubersUP

07/13/20 2:10 PM

#310902 RE: Barron4664 #310802

Interesting. Thanks
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Empiricst1

07/13/20 4:26 PM

#310951 RE: Barron4664 #310802

Great research, and all correct. The problem, and there is a problem, is that these laws and regs. are being administer by Dickheads, sorry for the crudity, but I could find no more accurate term. If the sensitivity to national preparedness and response would have been taken seriously, creatively and wisely, BARDA would have been all over B months ago, the Strategic National Stockpile would have been stocked with billions (yes billions of ppe), the NDMS and the USPHS would have been deployed en masse to do contact tracing 3-4 months ago, when it was realistic, as opposed to now, when it is not. I could go on. I worked there for a while and tend to be biased for them, but reality bites. Can I blame presidential appointees, to some extent, to the US Public Health Service (the sycophants in sort of Navy uniforms), hovering about the "leaders," and others? It is just not working. No one wants to read a thom on why, it's not relevant, and just mo anyway. We need a new cast of leading characters, and it goes farther back than just 3 1/2 years.