(Total Views: 381)
Posted On: 01/27/2022 3:05:42 PM
Post# of 154013
Re: craigakess #116416
Ohm is once again Correct here.
“If the company determines that disclosure is required, it should include appropriate caveats regarding the company’s stage of analysis, including whether only topline data was reviewed and what additional data is expected to be reviewed and, if applicable, will be disclosed. Great care should always be taken to not overstate the effectiveness of the company’s product”
“In conclusion, the most effective ways to minimize enforcement and litigation risk are ensuring that the company carefully and thoughtfully considers its clinical trial disclosures. Companies can avoid stressful situations by implementing protocols and processes that ensure all necessary parties have adequate time to review disclosures and understand the underlying clinical trial results. At a minimum, life sciences companies should engage with their SEC and FDA counsel well in advance of any interim or full results readouts to plan for disclosure in the event the results are good, bad or ugly”
No where does it say company must release trials trial data, its does say they must consider.
“If the company determines that disclosure is required, it should include appropriate caveats regarding the company’s stage of analysis, including whether only topline data was reviewed and what additional data is expected to be reviewed and, if applicable, will be disclosed. Great care should always be taken to not overstate the effectiveness of the company’s product”
“In conclusion, the most effective ways to minimize enforcement and litigation risk are ensuring that the company carefully and thoughtfully considers its clinical trial disclosures. Companies can avoid stressful situations by implementing protocols and processes that ensure all necessary parties have adequate time to review disclosures and understand the underlying clinical trial results. At a minimum, life sciences companies should engage with their SEC and FDA counsel well in advance of any interim or full results readouts to plan for disclosure in the event the results are good, bad or ugly”
No where does it say company must release trials trial data, its does say they must consider.
(1)
(0)
