RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
STAT New reports that that FDA appears to be losing some enthusiasm for issuing emergency use authorizations (EUA) for COVID-19 vaccines that would open the floodgates to widespread deployment.
Recent surveys have shown that a large portion of Americans would be reticent about vaccination over concerns that the vaccines have been rushed through the clinical trial and review processes without thorough vetting for safety.
Instead, the agency is apparently mulling an expanded access approach, a more limited program typically used for investigational drugs in areas of high unmet need, in the early stage of rollouts.
During yesterday’s FDA advisory committee meeting on COVID-19 vaccine approval criteria, Marion Gruber, director of the FDA’s Office of Vaccine Research and Review, said, “We are concerned about the risk that the use of a vaccine under an EUA would interfere with long-term assessment of safety and efficacy in ongoing trials and potentially even jeopardize product approval. And not only the first vaccine, but maybe even follow-on vaccines.”
University of Michigan’s Arnold Monto added that the maker of a COVID-19 vaccine that nabs an EUA nod might not be able to generate enough additional data to support full licensure.
Pfizer (PFE +1.7%) and partner BioNTech SE (BNTX +1.7%) appear to be the frontrunners to file an EUA application, expected around mid-November. Moderna (MRNA -2.2%) should follow in December if results from the Phase 3 COVE study are positive.
Selected tickers: AstraZeneca (AZN -0.3%), Johnson & Johnson (JNJ +0.2%), Sanofi (SNY +0.2%), GlaxoSmithKline (GSK +0.0%), Dynavax (DVAX -2.7%), Novavax (NVAX -3.5%)
The Financial Times reports that AstraZeneca’s (AZN -0.1%) COVID-19 vaccine agreement with the University of Oxford allows it to make up to 20% over material costs.
The company previously stated that it intends to sell the vaccine at no profit during the pandemic. The 20% gross margin is not inconsistent with this since other costs have to be accounted for.
ProPhase Labs (NASDAQ:PRPH) inked a definitive agreement to acquire a New Jersey-based Clinical Laboratory Improvement Amendments accredited laboratory (Confucius Plaza Medical Laboratory) which is approved for a variety of important medical tests, including COVID-19 and Respiratory Pathogen Panel Molecular tests.
Valued in an all-cash transaction at $2.5M, it is expected to close in short order.
The lab will be owned by its new subsidiary, ProPhase Diagnostics, formed to aggregate medical testing business opportunities and expand the lab’s capabilities and capacity.
The company expects additional laboratory equipment to be delivered and installed within the next few weeks which will enhance the company to process ~7K-8K COVID-19 tests/day.
ProPhase seeks to search for additional acquisition opportunities for expansion of testing capabilities and will seek for new business sources for Confucius Labs.
CordovaCann (OTCQB:LVRLF) entered into an arm’s length transaction via a non-binding letter of intent to purchase Washington-based Extraction Technologies, cannabis extraction services provider to multiple cannabis licensed processors within the State.
Proposed consideration for the transaction is 2M shares on closing date and 500K shares for every $125K in EBITDA generated by Extraction Tech during the 12-month period commencing post 3 years of transaction closure with maturing of 15 years.
Through the transaction, Cordova will provide manufactured cannabis products on both a white label and branded basis across the state of Washington.
Transaction expected to close on or before Dec.1.
The FDA has concluded its probe of two cases of a possible neurological side effect, and this afternoon told AstraZeneca (NASDAQ:AZN) it may resume the U.S. trial of its Covid-19 vaccine candidate, reports the WSJ.
The FDA concluded that the vaccine was not responsible for the issues, though it could not rule out a link, according to the story.
Prior to the trial halt, the vaccine had been one of the furthest along in development, and was perhaps on track for approval by year-end.
It was reported earlier this week that AZN’s trial (as well as J&J’s) was on track to get the go-ahead to resume.