Welcome To The Resverlogix HUB On AGORACOM

**Apabetalone (RVX-208) Currently Being Tested in a Phase 3 BETonMACE Cardiovascular Outcomes Trial and Will Soon Begin Phase 2a Kidney Dialysis and Phase 1 Fabry Disease Trials**

Free
Message: 3rd Quarter Financial Statements

Tada wrote: "I have heard from RVX in prior meetings as well as from at least 3 other biotech companies that once their IND is filed or the completion of this Type B meeting with the FDA has happened that the FDA has 30 days to respond to them if there is a problem that needs to be addressed. If there is no response within those 30 days then the results of the meeting or IND application are acceptable the way they are."

 

Correct me if I'm wrong, but it sounds like you are suggesting that completion of the Type B meeting with the FDA can be considered the equivalent of filing an IND. I disagree with your interpretation and have not seen or heard before that the Type B meeting can substitute for an IND application. 

In the February 23rd, 2017 news release, Resverlogix "announced the receipt of the final minutes of an in-person Type B meeting with the Cardiovascular and Renal Products Division of the U.S. Food and Drug Administration (FDA)." However, in that same news release, Resverlogix states "Resverlogix intends to file an official Investigative New Drug (IND) application and proceed with the planned Phase 2a clinical trial in 2017."

Furthermore, in the Feb 14th, 2017 BIO-CEO slides (slide 26), it states:

"Filed for a Type B Meeting early fall 2016

• Completed Type B Meeting late fall 2016, face to face in Washington

• Received positive feedback on trial design and positive instructions

to enhance the program without affecting the IND filing timeline

• New Cardio/Renal IND on track for Q1 2017"

Based on the language in the news release and from slide 26, it sounds like management still plans and intends on filing an IND. From page 11 of that pamphlet you cites, it states "All INDs are submitted to the FDA and proceed after 30 days if there is no additional feedback or restriction given from the agency." 

Do you know if the IND has been filed yet? Hopefully we will get an update on this from the slides or other communications related to the BIO Europe presentation tomorrow. If the IND has not been filed yet, then my impression is that the 30 day clock hasn't started yet.

Best regards,

BDAZ

 

Share
New Message
Please login to post a reply