Hello you wonderful and intelligent individuals that make up this forum. I sincerely hope you are doing well and keeping happy.
I have been following Theratechnologies Inc for a while now and they have a Prescription Drug User Fee Act goal date of 22nd January 2024 for the F8 formulation of Tesamorelin. Does anyone kindly please know if the FDA reviews are usually accurate to the goal date? If anyone kindly had any thoughts on this i would be forever grateful and thankful, it would be highly appreciated.
Sending you lots of good wishes and i truly hope everything continues to go well for you. Very best wishes.
The dates can change. A common reason is the FDA requiring additional information or the pharma itself submits additional data. I don’t know the percentages but if the company hasn’t announced a delay (or that they have submitted additional data or been asked for additional data) then I would imagine that there’s a good probability that there will be a decision (or update) by the set date.
Edit: ie if you are getting close to the date and there has been no announcement of delay then there will be an assumption that there has been no delay so an assumption that the company is expecting a decision by the date and thus the market will make a similar assumption. Requests or submission for/of additional data would normally be well below the decision date
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Happy New Year WakeMeUp, a massive thanks for being a huge credit to these forums and all the amazing information you provide. Thank you very much also for your response it really means alot.
I really appreciate your thoughts that if a company has not announced a delay (or that they have submitted additional data or been asked for additional data) you would imagine that there will be a decision (or update) by the set date. Thanks so much for sharing your thoughts on this.
Sending you lots of good wishes WakeMeUp and i truly hope everything continues to go well for you and you have a fantastic New Year. Very best wishes.