Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
This has been mentioned a few times by different bod members I wonder if an application has been submitted it is separate from the usual approvals. With the research now showing covid cases suffering from IPF it must be a possibility.
https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products
Try this the original
https://www.medscape.com/viewarticle/978522
Over 85% of shares are held by institutions, directors or hnwi leaving a free float of about 14.5m shares. Will take very little news for this to move.
Maven Income and Growth VCT1 10,611,864 11.08%
Downing 1 VCT plc2 10,611,864 11.08%
Santi – 1990 SL 10,386,182 10.84%
Chelverton Asset Management 5,681,818 5.93%
Octopus Investments 4,545,455 4.74%
Equipos Medicos-Biologicos SA 3,574,000 3.73%
David Evans 3,317,000 3.46%
Sonia Rodriguez Clemente 3,150,000 3.29
1 held via Maven Income and Growth plc, Maven Income and Growth VCT 3 plc, Maven Income and Growth VCT 4 plc and Maven Income and Growth VCT 5 plc
2 held via Downing 1 VCT plc and Downing 4 VCT plc.
Director Shareholdings
DIRECTOR NO. OF ORDINARY SHARES % OF ISSUED SHARE CAPITAL
Jordi Puig1,2 14,482,500 15.11%
Matthew Walls 10,762,500 11.23%
Sergio Olivero2 3,574,000 3.73%
Dan consultancy appointment from the RNS 2/3 “will now be brought to bear in a formal way, alongside the Nuformix team” intimating that he had already contributed informally, now on board does that mean talks are progressing the right way or was it just to appease those that moan.
Indiana University School of Medicine (“IU”). IU is the largest medical school in the US and will undertake a ‘Proof of Concept’ study using Cardio inCode-SCORE for the risk assessment of patients for onset of atherosclerotic cardiovascular disease (“ASCVD”). ASCVD accounts for over 85% of all cardiovascular disease deaths and is the leading cause of morbidity and mortality in the US and globally.
According to the Centres for Disease Control and Prevention (“CDC”), cardiovascular disease (“CVD”) is the number one cause of death in the United States and the decades-long trend towards lower cardiovascular mortality rates has begun to reverse, with an increase in total mortality during recent years: https://www.cdc.gov/heartdisease/facts.htm.
https://mobile.twitter.com/GenIncode/status/1552659719159947265/photo/1
Pre submission was 10th Jan, typically it takes 6 months, so approval can be any time;
“The average length of time for clearance under the traditional 510(k) pathway is 177 days, or nearly six months. Just 19% of devices on the 510(k) pathway are cleared within three months.
The average number of days it takes to clear a device via 510(k) varies according to the device category. Anesthesiology devices have the longest average length to approval, averaging 245 days. Toxicology devices are the shortest on-average, at just 163 days.
Please note that an overhaul of the 510(k) pathway is on the immediate horizon. It is unclear at this time whether these changes will impact the approval timeline. Learn more in 4 Reasons Overhauling FDA 510(k) is a Great Move.
The FDA medical device approval process is just one component of bringing a device to market. The length of time to approval for your device is likely to vary depending on whether you select the traditional or abbreviated 510(k) pathway, and according to your device class. However, if your Class 2 device qualifies for 510(k), it’s wise to anticipate approximately a six-month wait from the time your device application is submitted.”
https://www.qualio.com/blog/fda-medical-device-approval-process