Replies to post #239993 on Avid Bioservices Inc (CDMO)

[BioBS2012]

See answers in red - JMO ofcourse...

Guys, what about a designation? Recall Peregrine got FTD at about the same time as the start of SUNRISE. Now there's a lot of new information, including from SUNRISE, about bavituximab's MOA. What are the chances of getting a designation, be it FTD or something else, for any of the new trials:

1. Paclitaxel/Docetaxel + B, HER2- MBC, to be started before YE2015 - possible / priority review - depending on strength of data

2. Durvalumab + B in solid tumors, in 2016 - NO. Just signal indicating trial - could lead to one or more BTD's depending on data.

3. Durvalumab + B in sq+non-sq NSCLC, in 2016 - NO - as there is no data at present - Priority review possible - dependent on strength of data
4. HER2- early stage BC, under review - possible

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

[itsabouttime]

Speaking for myself everything is predicated on SUNRISE. No additional designations for the other trials. IMO



Guys, what about a designation? Recall Peregrine got FTD at about the same time as the start of SUNRISE. Now there's a lot of new information, including from SUNRISE, about bavituximab's MOA. What are the chances of getting a designation, be it FTD or something else, for any of the new trials:

1. Paclitaxel/Docetaxel + B, HER2- MBC, to be started before YE2015

2. Durvalumab + B in solid tumors, in 2016

3. Durvalumab + B in sq+non-sq NSCLC, in 2016

4. HER2- early stage BC, under review