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Interim Report Q1, 2021


Interim Report Q1, 2021
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Filing of New Drug Application submission to the FDA
Following the positive top line readout of our pivotal Phase 3 trial NefIgArd, which met both the primary and key secondary endpoints with results being statistically significant and clinically relevant we commenced the regulatory filing process which ultimately resulted in the timely filing of the submission to the FDA in Q1 as planned. In April, we received the response from the Food and Drug Administration (FDA) who accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. During Q1, we also submitted a request for accelerated assessment to the EMA, which was granted on April 23rd. These grants reflect the perceived unmet medical need in IgAN by regulators and, in my view, also the strength and overall quality of our dossier. ....

United States , United Kingdom , Mikael Widell , Exchange Commission , Committee For Human Medicinal Products , Drug Administration , European Medicine Agency , Vp Medical Affairs , New Drug Application , Priority Review , Prescription Drug User Fee Act , Iga Nephropathy , Human Medicinal Products , Nasdaq Stockholm , Nasdaq Global Select Market , Private Securities Litigation Reform Act , Calliditas Therapeutics , ஒன்றுபட்டது மாநிலங்களில் , ஒன்றுபட்டது கிஂக்டம் , மைக்கேல் வீடேல்ல் , பரிமாற்றம் தரகு , குழு க்கு மனிதன் மருத்துவ ப்ராடக்ட்ஸ் , வ்ப் மருத்துவ வாழ்க்கைத்தொழில்கள் , புதியது மருந்து விண்ணப்பம் , ப்ரையாரிடீ விமர்சனம் , ப்ரிஸ்க்ரிப்ஶந் மருந்து பயனர் கட்டணம் நாடகம் ,

COVID infections down in Texarkana


COVID infections down in Texarkana
(Source: WBTV File)
By Fred Gamble | April 16, 2021 at 1:20 PM CDT - Updated April 16 at 1:21 PM
TEXARKANA, Texas (KSLA) - Over 10,000 shots of the COVID-19 vaccine have been administered at Christus St. Michael Health System in Texarkana since Texas state leaders declared it a hub three months ago.
The results are positive for the community and health care providers.
“We are finally at a point in Texarkana where we can say that the number of people we have vaccinated has had a positive effect on our community,” said Dr. Loren Robinson, VP Medical Affairs.
Christus St. Michael Health Center, like other health care providers, has been affected by COVID-19. While treating patients many front-line workers have been infected with the virus. However, here at this Texarkana hospital employees began receiving a COVID vaccine this past December, and leaders are pleased with the results. ....

United States , Loren Robinson , Louise Thornell , Affairs At Christus St , Michael Health Center , Michael Health System In Texarkana , Vp Medical Affairs , Michael Health System , Vice President , Medical Affairs , Chief Nursing Officer Louise Thornell , ஒன்றுபட்டது மாநிலங்களில் , லோரன் ராபின்சன் , லூயிஸ் முள் , வாழ்க்கைத்தொழில்கள் இல் கிறிஸ்டஸ் ஸ்டம்ப் , மைக்கேல் ஆரோக்கியம் அமைப்பு இல் தெக்ஷற்க்கான , வ்ப் மருத்துவ வாழ்க்கைத்தொழில்கள் , மைக்கேல் ஆரோக்கியம் அமைப்பு , துணை ப்ரெஸிடெஂட் , மருத்துவ வாழ்க்கைத்தொழில்கள் ,