Can't remember one time when someone announced on a friday that they were having a call upcoming monday at 7:00am est to announce bad results. if it were bad just announce it friday after the close end of story. also why do you need to prepare several slides if it is bad...just my opinion hope iam right...but we only have to wait till monday....=)
The data was generated under a confidential agreement with the FDA. The first right of refusal is with the FDA agreeing that the data shows "statistically significant non-inferiority" or "statistically significant superiority." Any release of the data to any third party would constituted a breach of confidentiality. That is why. The only INSM announcement that testifies to this is the statement (sic) that the results from the 9 month dog carcinogenicity study were sent directly to the FDA. INSM did not say what the results indicated, although the inference was obvious.