...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Re: Looks like 0 participation in warrant incentive imo - answer to my email...
1
Jan 21, 2020 12:00AM

Tada - I would caution us in believing that we will get filled in on Breakthrough Status filings by mid-March. I hope we do but with the RVX history, I wouldn’t count on it. I can’t find any place that they said that they will inform us on it. I have looked at the AGM slides and listened to the webcast and there is no mention of BT at all. The Q&A is the only possible time it could have been mentioned but I was there and do not remember it being mentioned there. I couldn’t re-listen to the Nov. 18 and Dec. 6 webcasts but did look at the slide decks. You can see below that they only said it would be filed within 90 – 120 days which means the FDA might not even see this until mid-March. I hope a lot sooner but that is all they stated. We don’t want to turn their words to what we want and then feel they didn’t meet what they said. Also, they often don’t feel we need to know what they know. Financing is very material right now but they won’t inform us good or bad how the warrant incentive went.

Tada - “At the AGM it was said that RVX would be meeting with the FDA on Nov 13, on Nov 18ths web call it was stated that we would hear something about an application for something with the FDA in 90 to 120 days. This 90 to 120-day time frame was repeated again in the Dec06 web call.”

Tada – Not saying you said it was mentioned at AGM, I just checked to be sure. Dec. 6 slide deck item below:

Breakthrough Therapy status filings, both FDA and EMA, over the next 90-120 days

Nov. 18 slide deck item below:

Breakthrough Therapy status filings, both FDA and EMA, over the next 90-120 days

I have often heard a little confusion on what DM stated at the AGM regarding a Bolt-On Trial. When he described it, he referred to it as a, “pretty exciting option”.

He then moved on to another phase 3 trial and stated that we would need a partner in the following quote.

“don’t have horsepower to go back in there and do this without a major Pharma but we do, uh, well, guess I can’t talk about it. We’ll talk about it again after November 16th. We’ve got a lot of interest in this company right now.”

He didn’t exactly say that we needed a partner for a bolt-on, he said we needed it for a new Ph. 3 trial even though I believe we need it for a bolt-on also. What he was referring to when he said he couldn’t talk about it right then hasn’t been cleared up yet. Was it the BT filing, I don’t know but it would be nice to know? One might think with the sentences following that one that he was talking more of partners than the BT filing.

 

Bottom line is we will find out about this and the BT filing when RVX decides that they want us to and not by any schedule that we try to perceive.

 

Share
New Message
Please login to post a reply