Member Info for Borsaci06

he mentioned a new trial, called PrecISE, NIH funded for severe asthma patients, with new therapies considered for study as they become available.
https://www.kumc.edu/school-of-medicine/internal-medicine/divisions/pulmonary-critical-care-and-sleep-medicine/research/aatru/aatru-clinical-trials.html

can anyone see SNG will be in the trial ( PrecISE ) for severe asthma patients !?

a) None of the ordered Emergency Use Covid 19 vaccines can or will provide better immunity than an infection-recovered person;
b) All three of the EUA Covid 19 vaccines (Comirnaty is not available), in the age group and fitness level of my patients, are more risky, harmful and dangerous than having no vaccine at all, whether a person is Covid recovered or facing a Covid 19 infection;
c) Direct evidence exists and suggests that all persons who have received a Covid 19 Vaccine are damaged in their cardiovascular system in an irreparable and irrevocable manner;
d) Due to the Spike protein production that is engineered into the user’s genome, each such recipient of the Covid 19 Vaccines already has micro clots in their cardiovascular system that present a danger to their health and safety;
e) That such micro clots over time will become bigger clots by the very nature of the shape and composition of the Spike proteins being produced and said proteins are found throughout the user’s body, including the brain;

33. Finally, I have reviewed a recent study entitled “US COVID-19 Vaccines Proven to Cause More Harm than Good Based on Pivotal Clinical Trial Data Analyzed Using the Proper Scientific Endpoint, All Cause Severe Morbidity,” by J. Bart Classen, MD and published in Trends in Internal Medicine; August 25, 2021. Attached as Exhibit D.

THERESA MARIE LONG, MD, MPH, FS LTC, MEDICAL CORPS, U.S. Army

" 24. The shots carry mRNA that causes the recipient to create trillions of spike proteins.
This is a problem for five reasons.

First, it turns out that the spike proteins are not remaining locally in the (shoulder) injection site but have been found circulating in the blood and in virtually all organs of the body.

Second, the spike proteins themselves have been shown to be pathogenic (disease causing) attaching to endothelial, pulmonary and other cells, forming clots and attacking heart cells.

Third, the spike proteins and their lipid nanoparticles cross the blood brain barrier, with unknown long-term effects on the brain and high concern for chronic neurodegenerative disorders.

Fourth, these spike proteins interact in many signaling pathways which may trigger tumor formation, cancer, and other serious diseases.

Fifth, according to Pfizer’s Japanese distribution study of LNP accumulation, unexpected sequestering in reproductive organs and spleen raise very serious long-term concerns. "

" An additional peer-reviewed study not referenced in Dr. McCullough’s materials also supports the same conclusions drawn and reports that natural immunity provides a 13-fold better protection against Covid 19 infections than any currently available Covid 19 Vaccine "

" FDA Advisory Committee on September 17 of this year, fourteen of seventeen members voted against the authorization of any Covid booster vaccines in the juvenile age group "

all these & many more before a judge in court

AFFIDAVIT OF LTC. THERESA LONG M.D. IN SUPPORT OF A MOTION FOR A PRELIMINARY INJUNCTION ORDER

" 1. I make this affidavit, as a whistle blower under the Military Whistleblower Protection Act, Title 10 U.S.C. § 1034, in support of the above referenced MOTION as expert testimony in support thereof. "

" 22. Step 4: Implement Controls: Send out clear guidance to all DOD healthcare professionals on risks of-vaccination myocarditis. Compulsory SARs-CoV-2 mRNA vaccination program should be immediately suspended until research can be done to determine the true magnitude of risk of myocarditis in individuals who have been vaccinated. We must evaluate and immediately implement alternatives to mRNA vaccines, to include Ivermectin (FDA approved 1996), Remdesivir (FDA approved 2020), Hydroxychloroquine (FDA approved 1955), Regeneron (FDA EU approved 2020). Review VAERS data for deaths from COVID for age-matched data and data from active duty COVID deaths within the DOD to perform a risk/benefit analysis. "

https://www.deepcapture.com/2021/09/affidavit-of-ltc-theresa-long-m-d-in-support-of-a-motion-for-a-preliminary-injunction-order/?fbclid=IwAR1bt6koArLqSPpyGuaTJh162Hx-kgRU7Ef55JL6y-cJ6xKXSULCKXnRrrk

The FDA has determined it is unable to approve the NDA in its present form and has provided a list of issues to be addressed by the Company. These issues are mostly technical or manufacturing-related in nature and centre around the Xenon hyperpolariser system. Polarean will work to address the issues identified by the FDA with a view to resubmitting the NDA and securing FDA approval as quickly as possible. Following resubmission of the NDA, it is expected that the FDA review period will take 2-6 months.

can not find POLX on this PDUFA Calendar
https://www.biopharmcatalyst.com/calendars/pdufa-calendar

Content current as of: 10/05/2021
https://www.fda.gov/medical-devices/news-events-medical-devices/cdrhnew-news-and-updates

Content current as of: 10/04/2021
https://www.fda.gov/medical-devices/recently-approved-devices/2021-device-approvals

Hmm. We’re having trouble finding that site
http://accessdata.fda.gov/scripts/cder/d

maestro1

are you saying that FDA accepted NDA on 05 October & company RNS it on 23 December 2020?

Once the FDA accepts a filing for the approval of a drug, the agency must complete its review process within 10 months in most cases.
https://www.fool.com/investing/stock-market/market-sectors/healthcare/pharmaceutical-stocks/pdufa-date/

What percentage of PDUFA are approved?

In the first few years of the Prescription Drug User Fee Act (PDUFA) program,
the first cycle approval rate for new drugs was as low as 23 percent.
Now it is about 80 percent on average.

just a reminder
Stifel Nicolaus Europe Limited put their chance of approval at 90%.

RNS Number : 5951J on 23 December 2020 declares "Acceptance of NDA "

10 months from 23 December 2020 = 23 October 2021 Saturday

so FDA has at least 18 more days from yesterday
imho

How long does it take to get PDUFA approval?

PDUFA dates are deadlines for the FDA to review new drugs.
The FDA is normally given 10 months to review new drugs.
If a drug is selected for priority review, the FDA is allotted 6 months to review the drug.
These time frames begin on the date that an NDA is accepted by the FDA as complete.

think dates are confused, panic sellers helping others to accumulate

Prescription Drug User Fee Act (PDUFA VI)
Program fee
FY2021 = $336,432
FY2020 = $325,424
https://www.google.co.uk/search?q=pdufa+cost&ei=tl1dYfO1AZaDhbIP95WrwAQ&oq=pdufa+cost&gs_lcp=Cgdnd3Mtd2l6EAEYAzIFCAAQkQIyBQgAEJECMgUIABCRAjIFCAAQgAQyBQgAEIAEMgUIABCABDIFCAAQgAQyBQgAEIAEMgUIABCABDIFCAAQgAQ6BwgAEEcQsANKBAhBGABKBwhEGMzYhQFKBwhEGN3shQFKBAhDGANQguKFAViC4oUBYOv4hQFoAXACeACAAZMEiAGTBJIBAzUtMZgBAKABAcgBCMABAQ&sclient=gws-wiz

this fee paid to get some sort of outcome from FDA
is it safe to assume that fee spent for no news?

$AZN AZD7442 (long acting antibodies combo) Request for Emergency Use Authorization for COVID-19 Prophylaxis Filed in US
https://twitter.com/BertrandBio/status/1445345156237037568

wonder if reasonable endeavours are happy with the way their money being spent by mtph/mtp
judging by current SP,
PI here & USA seem not happy

Hi, Peelweight

just look for followings: year by year &/or page by page
Grant of Options
Exercise of Options

https://www.synairgen.com/tr-1-options-press-releases/#panel-2021

https://www.investegate.co.uk/CompData.aspx?code=SNG&tab=announcements

https://www.londonstockexchange.com/stock/SNG/synairgen-plc/analysis

they got millions of options, exercised 10 years old option due to expire.
last year & this year options could have been align with current SP but they chose to keep it @1p
it makes me think that they are not sure how this will play out (asthma/copd/covid) eventually [ making it to drug market ]

thats why posted some time ago ==> options @1p cover both 6p & 500p

It may be the pill
Anthony Fauci is after
time will tell

US Pharma group Merck will ask US regulators to authorise the first antiviral pill to treat Covid-19 after a clinical trial showed the drug cut the risk of hospitalisation or death in half
https://twitter.com/FinancialTimes/status/1443888785725460483