Theratechnologies Inc T.TH

RE:Major amendment and extend PDUFA date

[bfw]

JamesJack wrote: Here is one article about major amendment and when does FDA extend a pdufa date.
https://eyeonfda.com/2010/08/when-does-fda-extend-a-pdufa-date/

And you can see the PR announced by Taimed, translated by Baid:
https://m.moneydj.com/f1a.aspx?a=a94c8972-82ae-4e70-a2b3-b0a858a3cc90
The company received the FDA notification in November 13th in the United States, and extended the expiration date (PDUFA Date) of the TMB-355 drug certificate application for three months to April 3, 2018. In October 25th, Zhong Yu sent supplementary information on drug production and revised the original version. After initial reading, FDA decided that it would take more time to complete the review. The extension of three months is the standard procedure of FDA for extended review. In the letter, FDA did not ask Zhong Yu to provide more information.

Taimed sent supplementary information on drug production and revised the original version, the information is submitted to the FDA within 90 days of the PDUFA date, then the original PDUFA date will be extended.  

And as JFM's example, "FDA’s Delay in Approving Ocrevus is Normal Part of the Process".

After receiving supplemental information by end of October, then comes Thanksgiving and Christmas, no wonder Genentech and Taimed has to be extended the PDUFA date.

Excellent Post.

Very clear.

Major amendment

”that provides clarification about a manufacturing site”

Sounds like our situation.

The extension is standard based on facts noted above. There is not going to be another site visit IMHO.

bfw