|
|
|
|
||
Re: VERU-More ignorance by Scartet…I am a Veru Investor and thought of providing my opinion - 1) You do not publish entire data in public when you are looking for FDA Approval. You provide whatever information FDA asks and wait for FDA to make decision. Have you seen any data from Pfizer on bivalent vaccine. 2) FDA will make decision on dataset of 204 patients and we do not know the data of 204 patients. Only Veru and FDA have access to full data set of 204 patients. 3) As Adcom is scheduled we can agree that FDA agrees with the clinical trial framework and considers there is no fraud. Site investigations have cleared veru of any fraud in clinical trial. 4) The question is high death rate of Placebo in US. The question is if it is an outlier. Veru argument will be that as primary end point is death they enrolled very sick patients. Those who did not Sabi died and those who got sabi survived. US has the best standard of care and high death rate means the drug works. They have supporting data to show the death rate is lower outside where less sick people were enrolled. For the overall study of 204 patients placebo death rate is 29% and treatment arm is 15%. If you compare against Recovery-Baricitnib study that happened for 8000 patients at same time the placebo mortality rate was 9% (WHO 4) , 25% (WHO 5) and 38% (WHO 6) . Using the placebo mortality rate of Recovery-Baricitnib. you should see a placebo death rate of 22%. Point to consider - In the Study of Veru - WHO 4 patients needed to have comorbidity. that puts risk of death higher than 9%. Final placebo mortality rate is 29% and in treatment arm is 15%. that is 51% reduction We can ask for a larger study but it is very difficult to conduct a large study when death is used as primary efficacy point. You need to enroll very sick people with covid 19 and hope they agree to trial. If you enroll WHO 3 or normal WHO 4 patients the study will not show any benefit as people would not die. That is why MHRA and FDA are okay with the Trial size. EMA started a review of data based on request from Germany under article 18. There is CHMP meeting on second week of October and could bring a positive recommendation from EU. My personal opinion is there are some people at FDA who are corrupt. If you care for safety you will never approve bivalent vaccine on Kids over 5 years. Moderna has submitted for EUA and FDA has plans to approve it next month. |
return to message board, top of board |
Msg # | Subject | Author | Recs | Date Posted |
193046 | Re: VERU-More ignorance by Scartet… | MoneyMan01 | 2 | 9/25/2022 2:17:03 PM |
193051 | Re: VERU-More ignorance by Scartet… | redplate | 0 | 9/25/2022 3:25:27 PM |