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Message: Re: Breakthrough Therapy Question....response from IR
1
Jan 05, 2020 02:36PM
4
Jan 06, 2020 04:24PM

I agree that we can disagree if that makes sense :-)  

Its my belief that both statements of "90 to 120 days" made in November and December speak to the company being in the process of making an application for BTS. 

What this process involves, I'm having trouble finding anything definitive....there's plenty on what is needed to make the application, but I can't find anything on what the specfics of the process are.

I'm left to guess....I'm assuming it is not as simple as "fill out this form".  I'm thinking there is likely a back and forth between the regulating agencies and the company. 

The FDA/EMA are both bureaucracies, and I would not be surprised if, after submitting what they believed to be everything required...that notification could come saying something like:  "Our XYZ branch needs some more specific information related to the pre-clinical work done regarding the effect on enzyme ABC".  I'm likely displaying my lack of scientific background with that made-up example but I think I get my point across.  

In this type of scenario the 'non answer' I received from IR has a lot of logic.  Are the FDA and EMA in receipt of actual BTS filings?  I see it as potentially being a "kind of yes, kind of no" situation....with the regulating agencies at some point finally saying:  "Okay, we have enough information now, we'll give you our decision within the next two months".  

If I'm right about this, then it is  my expectation that this, (we'll get back to you in 60 days) would represent a material event that would require disclosure.  

I'm also thinking that in tandem with this back and forth that Resverlogix could also be in discussions with BP companies about licensing/partnership/M&A.  If either Apabetalone or the whole company were to be acquired, then the BTS as it relates to Resverlogix would be rendered moot imo.

Interesting times in any case, which seems par for the course ever since BETonMACE got rolling....lots to speculate on.  

 

 

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