Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

From Dr Joey on Facebook.

I know I've been more silent than usual lately, especially considering the recent material events. I WILL release a video this weekend. I've gotten the information I was waiting for, so my apologies for the delay. And, don't fret too much with the posturing going on. This is an alpha male gorilla chest-beating battle at the moment. If you get too emotionally evolved, you will get lost in the Fray (which is also a great throwback music group by the way ...not as good as Coldplay of course, but who is?)

Anyway, if you watch my video I recorded sometime in July, you will notice I said I absolutely hate making predictions regarding EUA. Part of that reason is because I was afraid this was going to come down to a manufacturing/ processing issue. Unfortunately, it has. This is my opinion, but the timeline matches perfectly. I'll go over it in my video. Basically, I said nothing would happen regarding EUA until after first week in August.

After first week in August, (08/09/21) is when we started seeing some action..... specifically regarding the FDA asking for more info and the USPTO statement of use being published as "under examination" along with published pictures of ZYESAMI (tm) AVIPTADIL. Here's the rub...I was curious if Dr. J was going to go forward with his thinking because he also attached RLF-100(002) as part of the labeling, which necessarily gives a tip of the hat to RLF100 being the prior art !!!?? This helps immensely on the scale of "obviousness" , plus in combination with the CA. Some of those are legal terms that u will get into this weekend, but I'm putting it out there now in case you want to research.
A couple of other things I've noticed along the way is that some of confusing CDER and CBER rules. In my opinion, Aviptadil falls under the small molecules, and therefore "CDER" , regulations. These are specialized subdivisions of the FDA. Aviptadil acetate is what ZYESAMI was touted as in former filings by NRXP. In other words, acetate denotes a necessary buffer! If those on YB remember, I discussed about acetic acid and its use regarding the inhaled form being a hinging issue as well. But, I'll tie everything together this weekend. Sorry for the delay and GLTA!

~ Bigdog, Y@h00 RLFTF finance conversations

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Reply:

Regarding the term RLF-100, even the Sec questioned Nrx in one of their filings to clarify it:

Business of NeuroRx, page 173 https://www.sec.gov/Archives/edgar/data/1719406/000119312521118944/filename1.htm

Sec:
"14. We note your references throughout to ZYESAMI, RLF-100, VIP and aviptadil. Based on the disclosure throughout your document, each of these terms appears to be a reference to the same product candidate. To the extent this is true, revise your disclosure to refer to this product candidate consistently throughout. Alternatively, please revise the beginning of this section to clearly explain the differences between ZYESAMI, RLF-100, VIP and aviptadil."

Nrx:
"Aviptadil is the generic name for synthetically-manufactured VIP, as distinct from the natural peptide. RLF-100 and ZYESAMI are both VIP-derived products, with ZYESAMI being a reformulation of RLF-100. We have revised the disclosures on page 179 of the Registration Statement as requested, and we have revised the disclosures throughout the Registration Statement to distinguish ZYESAMI, RLF-100, VIP and aviptadil."

Note that in one of Nrx's filings they discuss the Collaboration Agreement and it states:

"Each party will continue to own the intellectual property it possessed prior to the collaboration, and any intellectual property that is developed jointly by the parties relating to the RLF Product will be owned jointly by the parties and each party will have the right to use any joint intellectual property in its territory. Each Party is responsible for filing and prosecuting applications for patents, trademarks and other intellectual property in their respective territories and for the protection, maintenance, and enforcement of such intellectual property in such territory."

~ Zorro, Y@h00 RLFTF finance conversations