Since I am not qualified to delve into scientific discussions, I thought that it might be useful to have a closer look at the text of the Sep 30 webcast.  The webcast was definitely scripted since, as mentioned previously, I could hear a page turning during DMs portion of the presentation.  I suspect NWs was no different. 

Below is a condensed version of their presentation that I determined to be relevant. 

DM: We are clearly disappointed that the initial top line results for BETonMACE did not meet the rigorous academic requirements in confirming the primary endpoint.  This is in no way a signal of continuation problems for Apabetalone.  I believe future released data will confirm this drug works. This drug is safe. Properly partnered or financed, this drug will one day be a huge success. 

I have recently spoken individually with many of our lead investors.  We believe they will be following our preferred path of holding their stock while waiting for additional data and development plans.  Due to academic embargo rules, we are not yet in position to share additional important data that will be very enlightening for shareholders.

I believe our data sets, properly published and acknowledged by the academic community, will once again confirm the worthiness of Apabetalone.

NW: The primary endpoint of BETonMACE fell short of expectations, an outcome that none of us wanted to see. But the BETonMACE data set will contain extremely valuable information for continued development of this molecule.  In my mind, once the data has been presented it will be viewed as essential and most useful in bringing Apabetalone to the market.  The BETonMACE data set is an important step in making Apabetalone available to patients.

Clearly not everyone will have the same take on what DM and NW are trying to say, but for what it’s worth here is mine.

In the 1st paragraph above DM states that they are ‘clearly disappointed’.  I take that to mean devastated, and why shouldn’t they be?  It’s a big deal.  When he says ‘initial topline results’ I think he means exactly that…..initial topline results.  There are no subsequent topline results.  When he says ‘rigorous academic requirements’ I think he means the narrow 3pt. MACE and related Pvalue to a achieve a 95% CI.  In the world they live in anything less than a 0.05 Pvalue doesn’t really cut it…..at least that is my understanding.  He goes on to state that APL will continue and that future released data will confirm the drug works.  How far into the future are we talking?  Next month, next year or beyond?  We don’t know but he gives us a bit of a clue in the last line when he says ‘one day’.  To me that usually means what it says…..one day a ways down the road.

In the 2nd paragraph he says that the major shareholders will hold tight pending further data.  What else can they do?  Like most everyone else, they have to wait and see whether it’s worth pumping more money into the development of APL.

The last sentence in the 2nd paragraph is one of the most telling if this script was indeed carefully crafted.  This comment, ‘we are not yet in position to share additional important data that will be very enlightening for shareholders’ is where, IMO, DM is trying to tell us something.  He could have just stopped after the word ‘data’.  But no, he goes on to say that it ‘will be very enlightening for shareholders’.  Not ‘may’ but ‘will’. I know that this comment has been discussed in prior posts and I only mention it again here because it’s part of my commentary.  All I can say is that if this additional important data turns out to be not very enlightening then the comment borders on being misleading.  So, I’m assuming that a) they either know something already that they can’t yet divulge or, b) they are very bad at wordsmithing webcast scripts.

The last comment by DM that I’ve noted about publications, etc. ‘once again’ confirming the worthiness of apabetalone doesn’t say too much other than it implies this negative topline has made the perception somewhat ‘unworthy’, which why I think they are devastated.  A positive topline would have solved a whole lot of problems that they now cannot avoid.  I’m sure it sucks big time.

NW somewhat confirms their mood when he says that the primary endpoint ‘fell short of expectations’ and that it’s something ‘none of them wanted to see’.  However, he is focused on what the data will bring and its usefulness in terms of continuing development and bringing it to market.  Fair enough, but in the last sentence he sees this as an ‘important step’ in making APL available to patients.  Again, how long that step will take is anybody’s guess, but mine is probably not for awhile.

As sobering as my take on the above might be I think that it is important to note that all of the above is related more to the cardiovascular portion of the trial and not so much the CKD and Cognition sub-studies.  So, we still have that.  Further, strong mitigating factors in the full data release with respect to the primary endpoint will surely help to cushion the blow.  Let’s hope so.

P