RE:RE:Just an excuse to sell Iovance’s PDUFA date for lifileucel pushed due to FDA backlog
Iovance’s PDUFA date for lifileucel pushed due to FDA backlog
FDA won't extend the timeline without any explanation so they have most certainty informed the company for the reason of the delay. The timelines can be extended for various reasons During pandemic they missed many timelines due the disruptions/lack of resources but even after pandemic they missed some. Above is an example in 2023 and in this case the reason was also lack of resources. At the end of day it's either that or during/after their review they realized there is a need for additional calcifications. I guess we will find out "in due course" when that would be? Point is the importance of knowing how to word your message so it is clearly understood, minimizing speculations which could be outright false.
PWIB123 wrote: I'm not sure if you're referring to the statement about additional information provided in due course as the FDA asking for more informaiton or the company simply saying they'll provide more informaiton later, but I interpretted it as the company saying they will provide more information when they have it to provide.
All they had to do was add some clarification. FDA has informed they are going to need more time to review. No additional information has been requested at this time. No estimated timeline for a completed review was provided. We will update this press release if and when any additional details become available.
Boom! Take the edge off the situation a little bit. They are still absolutely terrible at communicating. They had to know this would hurt the stock value. Investors ALWAYS assume the worst, and these PDUFA date speculators are only in it for a few pennies. They are jumpy and scared. Definitely not long-term investors.
scarlet1967 wrote:
PDUFA goal dates are set after a regulatory filing is accepted, the dates aren't set in stone. The issue is they said "Further information will be provided in due course". One would expect if FDA was asking for additional information it should be included in the press release today but THTX loves opacity. Even if FDA wants more data it obviously doesn't mean the drug will
not get approved. As per Marathon there have been so many amendments but it seems like among others the condition for F8 approval by March 31, 2024 has been removed which costed company and its shareholders $.
It seems like due to previous miss steps and statements(like today's) which can be interpreted negatively anything not clear can be used as an excuse for selling. It's worth mentioning the sBLA was received and approved by FDA for their "substantial" review. Point is it could only be a bureaucratic delay which isn't unusual, it is all about clear communication otherwise the market expects the worse and for me the clear communication and lack of it is a major issue which company hasn't addressed yet and should!
"to remove the obligation to maintain at all times liquidity in the amount of US$30 million if the F8 formulation of tesamorelin is not approved by the United States Food and Drug Administration (“FDA”) by March 31, 2024;"
https://ca.finance.yahoo.com/news/theratechnologies-announces-agreement-principle-marathon-113000682.html