Here is what i've dug my shovel in to. "Noti
Post# of 5066
Posted On: 09/27/2013 6:31:15 PM
Here is what i've dug my shovel in to.
"Notification of Easily Correctable Deficiencies
CDER makes every effort to communicate promptly to applicants easily correctable deficiencies found during the review of an application. CDER also informs applicants of the need for more data or information, or for technical changes in the application needed to facilitate the agency's review. This type of early communication would not ordinarily apply to major scientific issues, which require consideration of the entire pending application by agency final decision makers as well as by reviewing staff. Instead, major scientific issues are usually addressed in an action letter at the end of the initial review process......." Well, you can read the rest of it here
http://www.fda.gov/drugs/developmentapprovalp...176522.htm
Also, if you are drinking alone at the bar tonight, read this. Informative document on animal toxicology data for IND applications. http://www.fda.gov/downloads/Drugs/GuidanceCo...071597.pdf
I'll bet things are fine. Maybe they need more current data before and during human trials to compare....well you can read up:-)
All-in-all, things are fine and will take a little longer than originally anticipated. IMO. This additional animal tests is most likely due to Orphan status goal of getting it to market fast. It was a lot to read and take in, but i feel the info we are looking for is there....except for the promo dump thing, but i've let that one go.
Have a good weekend all! Don't let this week get ya down. It'll be straight :-)
"Notification of Easily Correctable Deficiencies
CDER makes every effort to communicate promptly to applicants easily correctable deficiencies found during the review of an application. CDER also informs applicants of the need for more data or information, or for technical changes in the application needed to facilitate the agency's review. This type of early communication would not ordinarily apply to major scientific issues, which require consideration of the entire pending application by agency final decision makers as well as by reviewing staff. Instead, major scientific issues are usually addressed in an action letter at the end of the initial review process......." Well, you can read the rest of it here
http://www.fda.gov/drugs/developmentapprovalp...176522.htm
Also, if you are drinking alone at the bar tonight, read this. Informative document on animal toxicology data for IND applications. http://www.fda.gov/downloads/Drugs/GuidanceCo...071597.pdf
I'll bet things are fine. Maybe they need more current data before and during human trials to compare....well you can read up:-)
All-in-all, things are fine and will take a little longer than originally anticipated. IMO. This additional animal tests is most likely due to Orphan status goal of getting it to market fast. It was a lot to read and take in, but i feel the info we are looking for is there....except for the promo dump thing, but i've let that one go.
Have a good weekend all! Don't let this week get ya down. It'll be straight :-)
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