$UNCY CRL news: FDA issues Complete Response Letter on resubmitted OLC NDA. No clinical/safety concerns — issue is same third-party manufacturing deficiencies (inspection still pending). Labeling discussions ongoing. Company optimistic for quick resubmission post-inspection. Another delay likely pushes approval timeline out ~1 year.
Full details: https://t.co/mBLybYZ6JD
#UNCY #FDA #Biotech #KidneyDisease
@usembassysjo
Hello. My name is Shyam Dang. I and my family suffered major accident near San Jose on Jan. Have since been hospitalized at Metropolitan Hospital Santa Ana. We need help from the embassy for medical evacuation for specialized care
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@haodongvli I have a different take on $TVTX. FDA did not remove the REMS—it only reduced the monitoring frequency. There is still a boxed warning for liver toxicity. As a practicing nephrologist, it’s hard to justify prescribing this compared with atrasentan from Novartis.
@elonmusk@megynkelly If Imane Khelif has Androgen Insensitivity Syndrome—where she has XY chromosomes but female genitalia—she should be allowed to compete as female as excess testosterone doesn't confer the typical male advantage. This calls for nuanced understanding in sports. #AIS#SportsFairness
@elonmusk If Imane Khelif has Androgen Insensitivity Syndrome—where she has XY chromosomes but female genitalia—she should be allowed to compete as female as excess testosterone doesn't confer the typical male advantage. This calls for nuanced understanding in sports. #AIS#SportsFairness
#AnimalMovie - a very regressive, misogynistic movie. Has no real story, mish mash of Godfather, Kabir Singh. The only saving grace is the music. Absolute trash. Promotes violence and misogyny. @imvangasandeep is a total psychopath
@iamRashmika#AnimalMovie - a very regressive, misogynistic movie. Has no real story, mish mash of Godfather, Kabir Singh. Absolute filth. As a female, I am surprised you agreed to do the film. It promotes misogyny and violence.
@SamSiff#AnimalMovie - a very regressive, misogynistic movie. Has no real story, mish mash of Godfather, Kabir Singh. The only saving grace is the music. Absolute trash.
@Sports_bios $TVTX Highly doubt will get an approval. In IgAN- there was proteinuria decline but no statistically significant eGFR difference, with more hyperkalemia, AKI, hypotension. as clinician hesitant to prescribe given the current data
@DrDanMO There was decline in proteinuria but little decline in eGFR slope, just 1 ml/min, that too not statistically significant. The proteinuria decline may be explained by its hemodynamic effect. I will have a hard time prescribing it at a price tag of 100K/yr
@hswapnil FDA had granted them provisional approval. I doubt with this data they are going to get full approval. I couldn’t prescribe it for a marginal eGFr benefit that was not clinically significant
@BioStocks I doubt FDA is going to give them full approval with the current data. Also, with the difference in the eGFr decline being just 1.1, I am not sure that it justifies its price tag. As a clinician for now holding of prescribing it till see more