Followers | 144 |
Posts | 27707 |
Boards Moderated | 3 |
Alias Born | 02/07/2004 |
Thursday, August 20, 2020 10:32:02 AM
Aug. 19, 2020 9:39 AM ET|About: Kamada Ltd. (KMDA)|By: Douglas W. House, SA News Editor
Processors of antibody-rich convalescent plasma, derived from COVID-19 patients who have recovered from the infection, are under the gun on a delay of the expected emergency use authorization from the FDA for the treatment of COVID-19.
NIAID clinical director Dr. H. Clifford Lane says the authorization is on hold to allow for the review of more data since clinical trials have not proven that the plasma helps patients fight SARS-CoV-2.
Recent data from the largest study to date, conducted by the Mayo Clinic, were not strong enough to support emergency use approval according to top health officials, including NIAID's Dr. Anthony Fauci. Results involving more than 35K patients showed a lower mortality rate if the convalescent plasma was administered within three days of diagnosis compared to later administration but the study has no control group so it is not possible to confirm the treatment effect. Enrollment in the study has ballooned up to an "unmanageable" level says Dr. Lane.
A study in the Netherlands was stopped after investigators saw no difference in mortality, length of hospital stay or disease severity compared to placebo.
At least 10 randomized trials in the U.S. are struggling to recruit participants since they need to be sick and the pandemic is waning in many cities.
Selected tickers: Kamada (KMDA -8.8%), Grifols (GRFS +0.1%), XBiotech (XBIT -1.8%), Cerus (CERS -1.1%), ADMA Biologics (ADMA -8.3%)
https://seekingalpha.com/news/3607063-convalescent-plasma-players-under-pressure-on-fda-hold-on-emergency-use-nod
Recent KMDA News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/23/2024 11:00:24 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/14/2024 11:00:45 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/07/2024 11:00:29 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/08/2024 11:00:49 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 03/06/2024 12:10:12 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/28/2024 12:00:02 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/12/2024 05:41:57 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 12/28/2023 06:16:03 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/28/2023 02:30:02 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 12/19/2023 11:00:37 AM
- KEDRION ANNOUNCES AN EIGHT-YEAR EXTENSION OF THE DISTRIBUTION AGREEMENT WITH KAMADA IN THE US FOR KEDRAB® • PR Newswire (US) • 12/07/2023 04:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/06/2023 12:00:04 PM
- Form 6-K/A - Report of foreign issuer [Rules 13a-16 and 15d-16]: [Amend] • Edgar (US Regulatory) • 11/13/2023 03:04:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/13/2023 01:00:04 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/13/2023 12:00:29 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/08/2023 12:00:31 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 10/16/2023 11:00:13 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 10/10/2023 11:30:16 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM