ASRT (MC $100M) FDA Decision on October 19=200%++Potential Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : ASRT (MC $100M) FDA Decision on October 19=200%++Potential

ASRT 0.746

-0.5%

Oct 31 9:30 AM EDT

Public Reply Prvt Reply Mark as Last Read File

Previous 10 PreviousNext

From: BioHero	10/8/2019 11:26:09 AM
	of 2

Guys better 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 fool.com 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.

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 PreviousNext