InvestorsHub Logo
Followers 0
Posts 596
Boards Moderated 0
Alias Born 05/15/2017

Re: None

Tuesday, 10/08/2019 11:28:21 AM

Tuesday, October 08, 2019 11:28:21 AM

Post# of 642341
ASRT..BIG risk guys read

Guys may be its better to avoid this stock there is some manufacturing risk so FDA likely to reject the drug .I dont know if they resolved that issue but i think its better to avoid the stock but its your own decision .GL

https://www.fool.com/earnings/call-transcripts/2019/08/08/assertio-therapeutics-inc-asrt-q2-2019-earnings-ca.aspx

With regard to our NDA filing for our long-acting cosyntropin for the diagnosis of adrenocortical insufficiency, our filing remains under active review, and we continue to move forward toward a scheduled PDUFA date of October 19. Our partner, West, the product supplier and IND holder, continues to investigate the manufacturing issue we discussed at our first-quarter earnings call.

The significance of these manufacturing models remains unclear. However, if these manufacturing issues are not resolved in a timely manner, it is possible this could impact cosyntropin approval, or if approved, we may not be able to launch the products until these issues are resolved.

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.