But I guess that’s your job is to discount any positive news and only emphasize the FDA which we have not submitted for yet. But our FDA will look quite foolish when the UK approves our drug they will have to approve it almost whether they like it or not concern for basher like yourself , for some reason should want a better treatment, but for whatever reason you guys would provide a roadblock to approval. Within three months it won’t matter DC VAX will be approved in the UK.
NWBO did adhere to the patient patient-level data. as set by the FDA lying basher shortie NWBO did however not meet the patient-level data requirements as made up by you and ex.
During the submission process, researchers will need to show the patient-level data used to create their ECA along with the corresponding data from the investigational arm. The Clinical Data Interchange Standards Consortium’s (CDISC’s) Study Data Tabulation Model (SDTM) is typically used for data submitted to the regulatory agencies, but sponsors may wish to discuss other appropriate data standards and current requirements with the review division, if necessary.
Hoping the company’s bullshit redo of the trial gets around the FDAs REQUIREMENT of patient level data for the ECA isn’t just wishful thinking, it’s absurdity.
There you go again I C the light, spewing mombo jumbo trying to throw bullshit to see if it sticks to the wall. Truth be told you haven’t seen the light. Read the Journal Article. Statically Significant over SOC and SEE THE LIGHT!
Too many red flags on BS trial. Would have been rejected on the spot if they submitted this garbage to the FDA. Moving this to the UK and building up the CDMO there AGAIN. You can just put 2 + 2 together, and you can see this getting rejected a mile away.