The latest Investing Matters Podcast episode featuring financial educator and author Jared Dillian has been released. Listen here.
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.
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
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
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
RNS Number : 3710A
29 September 2020
“Company has made good progress with discussions with a variety of international suppliers to scale up production of SNG001 rapidly, with the aim of being able to produce approximately 100,000 treatments per month in 2021“
RNS Number : 4655N
30 September 2021
“Company expects to have tens of thousands of treatment courses available to the market should an EUA be granted. With government support, the Company has the potential to increase capacity to approximately 100,000 treatment courses per month”
so government support is required after 12 months, big pharma cannot / will not help out
that list exists for months,
SNG is there for months
last update about synairgen done on 08.09.2021
need an access to see whats written on google docs.
https://docs.google.com/document/d/1Y4nCJJ4njzD1wiHbufCY6gqfRmj49Qn_qNgOJD62Wik/edit
CMS2
5ed67f835243b0a13fae4308
synairgen #292
https://airtable.com/shrSAi6t5WFwqo3GM/tblEzPQS5fnc0FHYR/viwJJuMA1ioIgAcPs?blocks=bipZFzhJ7wHPv7x9z
Dr. Fauci: I want a pill that blocks a specific viral function.
https://tinyurl.com/8vxu84mu
https://www.csis.org/analysis/conversation-dr-anthony-fauci-antiviral-program-pandemics
mtph targeting
*LAI market with Q-Sphera ( Long-acting injectables using printed microsphere technology )
*MidaSolve –MTX110 for DIPG ( panobinostat infusion with CED Intratumoral brain cancer treatment dipg )
https://www.midatechpharma.com/media/pages/investors/presentations-and-webcasts/98d47e6c68-1626951755/21.06.19-mtph-corporate-overview-june-2021.pdf
For example, at oil prices of US$70 per barrel,
the cost of CO2 is around US$30/tCO2 [27].
Hence, as a result, multiple CCS projects in the USA have come online during periods of high oil prices
https://academic.oup.com/ce/article/4/1/2/5686277?login=true