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As you noted the study quoted in Natural News does not have anything to do with covid. It is a study investigating interaction between lung microbiome and lung cancer. Further more, there is still the usual causality problem: does increased lung microbiome instigate cancer or does existing cancer instigate the growth of lung microbiome?
However, I have a proposal to the splendid staff of Natural News: please fund the following study.
We all know that surgeons do wear masks during operation, some of them several hours per day. We should compare surgeons spending more time in operating room to those who spend less. If it turns out that the surgeons who do spend more time in operating room have significantly more lung complications we have our answer. And remedy to obvious threat to successful surgical career: ban masks from operating room.
I feel certain that Natural News does not see any problems with this.
Sheehs, my bad, one should never read only headlines.. but then there are, of course, the official guide lines, which make an attempt to clarify. Quote:
Dear Doctor, I got beatifully backwards. Australia has recommended that people UNDER 50 take ONLY Pfizer vaccine. see here:
https://www.bioworld.com/articles/505794-astrazeneca-vaccine-risk-prompts-australian-government-to-recommend-pfizer-covid-19-vaccine-for-under-50
You may be thinking of Pfizer's vaccine. It requires -70 C storage temperature compared to Moderna's -20 C. Problems both.
It is not so bad, actually. I found it funny that one of the docs at Researchgate was annoyed over the failure of Koch instute's test to discriminate between SARS-CoV and SARS-CoV-2. SARS-CoV is the original Severe Acute Respiratory Syndrome virus. Simple method of differentiating: Just watch for a while at the person being tested. If he/she keeps on breathing then it is SARS-CoV-2, if not, then it is SARS-CoV.
An exaggeration, of course. But, original SARS-CoV is far more serious customer that CoV-2. I would not call it a bad thing if a test detects both. Actually, there are some scientists who maintain that Covid-19 is just mutated SARS.
No it does not mean that virus has not been isolated. It means that at the time of this particular testing "no quantified virus isolates of the 2019-nCoV" were available. Canadian's had a related problem earlier:
https://theconversation.com/i-study-viruses-how-our-team-isolated-the-new-coronavirus-to-fight-the-global-pandemic-133675
Makes sense. Lock-downs do have tremendous societal costs.
Well said, rumpus.
Yes, from the much maligned anecdotal evidenced front: my relatives over there are telling me that the life is getting complicated, again.
I guess you consider Mayo Clinic and American Journal of Managed Care being a part of hypoteticals pumping media.
Look, I give you this: The whole covid-19 situation could have been better managed. It's probable that early and sufficient supply of masks with proper guidelines for their use would have lessened the need for more drastic measures.
Maybe prof is saying that considering only fatalities is limited view of the risks associated with covid-19. There is mounting evidence of long lasting, possibly permanent, damage to lungs, kidney, heart muscle and even brain.
I don't relish the thought being transformed to foggy brained, seizure prone covid-19 survivor with bad ticker and leaky kidneys.
https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-long-term-effects/art-20490351
https://www.ajmc.com/view/most-americans-unaware-of-covid19s-effects-on-the-kidneys
IPIX press release looks like it could have been written by me - it is confusing. Hmm, that may be the reason ... never mind.
This much I think is clear: IPIX has sent pre-IND application and FDA has responded.
And this is my interpretation of IPIX press release.
The press release does not say that pre-IND meeting process is completed. If it were IPIX would have said so, for instance, by telling us they are now proceeding to file or have already filed an IND request with FDA. That would be the next logical step after completed pre-IND meeting. IPIX does not say anything like that. Instead they are describing the nature of their pre-IND process with FDA. Probably in order to stress that they think when they get OK from FDA, they can skip safety studies and go directly to P2.
Great response, LR, beautifully done butt-slapping.
I admit that I did not read Dane's post properly. I should take writing lessons from you. Seriously.
Naah. If I were a hedge fund guy, that fund would have been past court ordered post-mortem long time a ago. I post on IPIX board because I own a chuck of IPIX shares plus I find some people here interesting and articulate. The Latter just might explain why I don't post on some other boards, even if I own shares.
Besides, I am mildly dyslectic, hence a slow typist. I have to pick my spots.
LR and DaDane, it is a deep muddy swamp you both are wading in. Here is one example of valiant efforts to make some sort of sensible morbidity rate comparison between covid and flu. Read the update at the end of article, especially the update.
https://medium.com/microbial-instincts/clarifying-the-true-fatality-rate-of-covid-19-same-as-the-flu-8148e38b9ab5
[intermission to allow for long exasperated reading of the above article]
CFR, IFR, Spanish flu, Seasonal flu? Oh my!
Are you enlightened now? Got clarity? I am not and I didn't. But that just me, unlettered rustic bumpkin.
KMBJN, thanks for the link. Among other very educational things it even manages to make sense about Swedish approach.
I know, consider my post as supporting fire.
Regeneron's antibody cocktail. Link
https://investor.regeneron.com/news-releases/news-release-details/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and
Why are they giving cocktails to a teetotaler? Swines! Taking advantage of weakened resistance to temptation.
There are studies showing that wearing masks have benefit:
here is two:
https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.00818
https://www.researchgate.net/publication/342198360_Association_of_country-wide_coronavirus_mortality_with_demographics_testing_lockdowns_and_public_wearing_of_masks_Update_June_15_2020
Then there is 'anecdotal evidence' like why did Australia have a mild flu season this time:
https://www.healthline.com/health-news/australia-mild-flu-season-what-means-for-the-united-states
While I am at it I like to address false equivalency that keeps popping up in some posts here. Comparing 'normal' flu deaths (anywhere to 30k to 120k) to current crop of covid-19 deaths (about 200k now) and then saying no big deal. Sorry, those covid deaths are affected by social distancing, close downs and mask wearing. Flu deaths were not mitigated in any way. False equivalency!
More like a fake peptide. B mimics the molecular structure of a peptide without being one. Hence the moniker peptide mimic.
LR, you are correct. I, your always realiable nitwit, did wander on the granted patents side. But, it seems that PreGrant Application Database behaves the same way.
APD/4/$/2020 8248 hits
APD/5/$/2020 6137 hits
At this point results page name changes in my Firefox browser tabs from PreGrant Publication Database to Published Application Database
APD/6/$/2020 0
APD/7/$/2020 0
APD/8/$/2020 0
It may be as other posters have said that newer applications are confidential. Otherwise it is hard to explain the results, unless the search engine or database is broken ... I think we can't say anything definite about Leo's application. There is no proof in this pudding.
See it yourself:
May 2020
http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=0&p=1&f=S&l=50&Query=APD%2F5%2F%24%2F2020%0D%0A&d=PG01
June 2020
http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=0&p=1&f=S&l=50&Query=APD%2F6%2F%24%2F2020%0D%0A&d=PG01
LR here is something for you to ponder:
On USPTO's very helpful help pages they say that a search string APD/month/$/year should return applications filed on a given month of a given year.
Being of curious kind I tried:
APD/3/$/2020 should return applied in March 2020.
I got 409 hits
APD/4/$/2020 should return applied in April 2020.
I got 241 hits
APD/5/$/2020 should return applied in May 2020.
I got 132 hits
APD/6/$/2020 should return applied in June 2020.
I got 9 hits
APD/7/$/2020 should return applied in July 2020.
I got 2 hits
APD/8/$/2020 should return applied in August 2020.
I got 0 hits
APD/9/$/2020 should return applied in September 2020, so far.
I got 0 hits
Some possible interpretations:
A. Nobody has filed for a patent since July 2020 which means that nobody is filing for patents anymore (why bother). Corollary: because nobody obviously includes Leo, Leo has not filed for a patent.
B. USPTO's search engine is broken (is that a surprise?). Corollary: we don't know if Leo has filed for a patent.
C. As my late wife (Ph.D. patent agent) used to state in rather salty language - there is significant delay between the ACTUAL filing date and the date when the application shows up in USPTO's search results. Corollary: we don't know if Leo has filed for a patent.
And you couldn't find any denser explanation, eh? My brain is aching, some sort of steam is coming out of my ears. Can human brain overheat and seize like an engine?
Seriously, thanks for posting this.
You want more weirdness?
IPIX announces positive in vitro results involving P53 and it's the competitor's share price that jumps! Of course there is logic in this, but I leave it to others to explain.
As it says in the press release. Brilacidin for treatment of unmentionable ailments with unpronounceable names was licensed to Alfasigma. A trial was supposed to commence mid-2020, but is probably on hold due to another ailment going on globally.
Answer to your remark:
"You know that stuff is over my head". I beg to differ, it is not. Staying with Galera for a while. I did some experimenting with those swim-lane values. It seems that even that difference between treatment and placebo should be enough for success in phase 3. My biggest worry is this: what ever I try, I am unable to reconcile placebo swim-lanes with other Galera data for placebo. Maybe they censored some subjects - I don't like that. Well, we should see in October-November time frame.
As to any future IPIX P3 trial. Nobody knows. I am afraid when one possibly comes along, Leo The Clinical Skin-Flint somehow manages to run too small trial, again. I am fairly certain that if either SOM or UPS trial had been done with properly sized population, not with moonshot population, we would now be discussing when we think IPIX P3 results are coming out.
Of course, some will point to thin funds when those trials were done.
Oh my, I see some familiar aliases here. Good. I can then address this rant to you, Loanranger. In the past, you have shown remarkable tolerance of my messages, even long ones.
I have, or better said, have tried to do some checking of Galera's claims found in the report from GC4419 PIIb trial for SOM. I got outright giddy when I noticed that they have included SOM incidence and duration swim-lane chart. Hah, nitwits are providing me the means to do thorough checking of ALL REPORTED VALUES. I should have known better.
Obvious sign of trouble besides missing headcounts in table 2 is that in the said table Galera reports median duration of SOM for GC4419 90 mg dose as 1.5 days. If you check the swim-lane chart you see that for 90 mg dose there is total 35 SOM incidents. Headcount for intent to treat group for 90 mg dose happens to be 76. How can one get SOM median 1.5 days when less than 50 % of subjects did ever experience it? Of course, one can't. More misery can be found in the statistical methods section:
CDC has a visualization of excess deaths due covid-19 plus underlying data available. see here
https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm
In mid August NY Times did an article based on CDC data.
https://www.nytimes.com/interactive/2020/08/12/us/covid-deaths-us.html
I did some reading this week and learned mostly unhelpful things. Farrell and others have covered most that follows before, but it is still worth repeating.
How does SARS-CoV-2 virus enter human cells?
It is known that cell entry by the coronavirus requires the binding of the S1 region of the virus spike (S) protein to the cell surface receptor followed by the fusion of the viral and cellular membranes mediated by the S2 subunit of S protein. This process requires S protein priming by host cell proteases, which entails S protein cleavage at the boundary of S1 and S2 proteins or within the S2 subunit. SARS-CoV-2 utilizes angiotensin-converting enzyme 2 (ACE2) as cell entry receptor and transmembrane serine protease 2 (TMPRSS2) and/or the endosomal cysteine proteases cathepsin B and L (CatB/L) for S protein priming. It is thought that TMPRSS2 activity is essential for viral spread. Alveolar type 2 cells in lungs highly express both ACE2 and TMPRSS2.
The above is probably no news for most people around here. Well, here comes the distressing part of my findings. It turns out that SARS-CoV-2 can utilized some other receptors for entry, although using ACE2 remains the most efficient entry method. Among alternate entries are CD209 and CD209L. CD209L is expressed in lung and kidney epithelial cells and in endothelial cells of small and medium-sized vessels. Then there seems to be cell entry methods utilizing Neuropilin receptors and CD147/Basigin receptor. Note to male readers: CD147 is important in spermatogenesis and its presence in entry point list may explain why SARS-CoV-2 has been found in testes.
I occurred to me that any single inhibitor or receptor blocker needs be to amazingly talented if it intends to be successful. I would say that preventing SARS-CoV-2 cell entry will require quite a cocktail of antivirals. And I am talking only about cell entry. What happens after entry is another story.
It might be better if we had a treatment that would outright kill the virus instead of trying to inhibit or block. Has anybody around here heard of this kind of drug? It would be helpful if it is already proven to be safe in humans.
For additional reading:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7407648/
Not much argument from me. We really don't have firm data to support any declaration of victory. Feelings and opinions only. I do have a feeling, and feeling only, that Brilacidin will inhibit SARS-CoV-2 virus in human. By how much (is it sufficient?) and at what concentration (is it clearly on the safe side) is anybody's guess.
Possibly interesting developments:
I read few days ago that scientists in Europe are baffled with these new jumps in covid cases. They are complaining about too few hospitalizations and fatalities compared to spring. Even accounting for improved treatment and younger patients. Maybe this darn wily virus has mutated again. I am getting a sense that covid likes to do mutating on European soil - civilized fella, have to admit. If this keeps up we will end up with new variant as deadly as common cold.
I hear you, TIAB. I will refrain on commenting on probability of Brilacidin covid trial. Not because of brotherly love, but because my probability sensors have obviously gone on the fritz - based on how some of my 'high probability of success' investments are behaving lately. Even my assumers are getting flaky.
No, you are the one mistaken, and badly. let's first quote Dr. Fauci on this:
Maybe you should familiarize yourself with the story of Akira Endo and statins or maybe how Gleevec finally ended being a cancer drug. Strange things do happen when wrong information gets around.
The book "Loonshots" has been recommended around here before. I repeat the recommendation. And I add another:
The Emperor of All Maladies by Siddhartha Mukherjee
Yes, I do think that DeGrado knows someone more than suitable. The real question is if that someone is available.
Like who will be the Covid trial PI?
Helluva good question. None of the current crop of IPIX scientific advisors do fit. Even less so with board of directors. Additional confounding factor, I am afraid, is that there are so many covid trials running currently. Most of the prominent and slightly less prominent virologists are probably fully occupied.
Correct. My mistake. I was thinking of Polymedix.
I agree, numbness and tingling are not serious. But what IPIX or defunct Cellceutix think does not prevent FDA asking formal clarifications. And for that I want DeGrado being available. It is that simple.
I am ashamed to admit, that I, too, have never been present at FDA meeting (hopefully banishment from this board does not follow this revelation). But I have this despicable old-fashioned habit of reading. Hence, over the years I have gone thru, about 50, maybe more, FDA drug acceptance packages and probably dozen or so advisory board meeting prep-materials plus transcripts. In normal times Brilacidin might end up in advisory board meeting. FDA tends to do that with first approval of a drug with novel MOA. I don't see it happening now.
Written submission is not just company sending completed application and FDA reading it and then saying either yay or nay. If you read some of the administrative actions included in approval packages you will notice that FDA will ask additional data, clarifications, object to certain wording and claims and so fort. Sometimes they even launch an investigation of their own. And that starts at pharmacological review. Leo can't answers to any queries, hired trial runners to those pertaining only to trial itself. DeGrado is able to answer to pharmacology and microbiology questions. Those are on his field of expertise.
As to DeGrado being at meetings. Only if necessary.
I recommend reading material available in FDA approval packages and especially FDA advisory board materials. It is mostly boring going but sometimes it can be educational, hilarious (some geezers at advisory boards) and even infuriating (FDA 'political' agenda shining thru). Yes, politics and personal dislikes are involved, occasionally.
Farrell90. I was trying to make a point why DeGrado is a good person to have onboard, be it in exchange of letters with FDA or in actual meetings. Now about he numbers
From Polymedix presentation:
paraesthesia
1. dose- depended; reported at ≥0.3 mg/kg in 60-100% of subjects
2. mild to moderate in intensity
3. resolved without treatment within 3 to 9 days
Cellceutix phase IIb trial dosing 0.6 mg/kg to 0.8 mg/kg. about 60 % of subjects with numbness or tinging (paraesthesia). However, no treatment related SAEs.
Using 70 kg skinny body weight and 4 to 5 liter large blood volume Cellceutix dose numbers translate to range 8 - 15 uM (if web calculators work correctly). Leo stated that IC90 in human lung cells is in low uM range.
Conclusion: FDA may want to discuss about paraesthesia. Does that mean they are willing to reject Brilacidin? Hardly!
Some sources:
Short discussion about paraesthesia as it relates to brilacidin
https://www.businesswire.com/news/home/20110512005450/en/PolyMedix-Presents-Clinical-Pre-Clinical-Data-PMX-30063-Defensin-Mimetic
Cellceutix presentation that covers dosing in both Brilacidin trials.
https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f8286d2b85731b8713a36/1480557192947/A-Randomized-Double-Blind-Study-Comparing-Single-Dose-and-Short-Course-Brilacidin-to-Daptomycin-in-the-Treatment-of-Acute-Bacterial-Skin-Skin-Structure-Infections-ABSSSI1.pdf
conversion calculator:
https://www.graphpad.com/quickcalcs/Molarityform.cfm