Theratechnologies Inc T.TH

Just an excuse to sell

[scarlet1967]

 

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

[palinc2000]

The PR could have been more informative,I may be wrong but I somehow doubt that the Letter from FDA was just a one sentence document with absolutely no reasons given  for the delay... Of course it could have been worst with a CRL .... I still think it will be approved and the market reaction is irrational since the SP did not include with the recent retracement any value for F 8.....

[Trogarzon]

It's like having an engeneer or an accountant at PR department.  I want to beleive they have a legal obligation to be so uncommunicative or bad at it.

[scarlet1967]

I also believe the drop isn't warranted and the drug gets approved eventually. I definitely believe the company should communicate the reason for the extension and elaborate on what if any additional actions are planned to deal with the enquiries if any. There is no reason for not being more specific. There have cases when FDA has extended their review process due to resource shortages also of

[Trogarzon]

Hey maybe their friends are buying today and the stock will be 4$ friday and round goes the world of finance....

[PWIB123]

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

[Saurus100]

I agree with you, the statement you are proposing would have been better.   

[scarlet1967]

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