RE:Just an excuse to sellThe 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.....
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