Replies to post #166786 on Avid Bioservices Inc (CDMO)

[volgoat]

No

[EYEBUYSTOX]

At UTSW...yes...they control the data flow there as it pertains to Brekken's lab and PS IMO.

[goodplenty100]

bidrite, don't know if this may help, but I did remember this.

One of the main benefits of fast-track designation is increased communication between the sponsor and FDA.[5] Regularly scheduled meetings with FDA, including a pre-IND meeting and meetings at the end of Phase I and II studies, are held to obtain input into clinical plans. In addition, a meeting is held with FDA before submitting the NDA or BLA to obtain input on the format of these applications. Other potential benefits of receiving fast-track designation are the increase in written correspondence between the sponsor and FDA and the "rolling submission" in which the BLA or NDA may be submitted and reviewed in portions rather than in one complete package.

Taken from http://www.medscape.com/viewarticle/449551_3

GL