FROM FRESENIUS' CONFERENCE CALL YESTERDAY...PUBLISHED ON SEEKING ALPHA, THIS PASSAGE ON PAGE 7 Q&A OF CHAIRMAN:
Michael, on OMONTYS, your timing's impeccable. What I can tell you is that Takeda has been working with FDA and they are just almost at the point of getting agreement with FDA on a study that will be done in our clinics. It is a DNA type of study where they're going to be trying to understand what could potentially be within the individual that had the reactions, is there something we can learn and understand there? So it's a fairly scientific approach to what we're trying to do. But they continue to work and be very active in understanding what went wrong. So that is an update for you. And as I say, we'll be participating in that study. And I don't know how long it will take, I'll have to talk to the medical guys and see what they think it will take in terms of timing and evaluation of the data, things of that nature. But you should know that they have not stopped, they are continuing to work in trying to understand how they can make this better understood, if you will.
What he is stating sounds like a science project. I doubt this guy has any idea what they are doing with the FDA other than the fact some testing is going to happen at his facilities. Takeda is smarter than that to know that to detect a .02% reaction rate will require a sample size of tens of thousands and to find a common DNA is like trying to find a needle in a haystack. The good news is that TAkeda is moving forward and smart money will be buying today.
Ya man this is good. More news will keep stock crankn up. But it's guna b months till that O new comes out. Ugghhhhhh.i kno ima make som good cash on this. Jus sucks cuz i got a large amount of money in affy so I can't do a lot a trading elsewhere. But ya let's do this shet
Yes. But we have no idea when this will be resoled. That is troubling. While the stock moves higher on no news directly linked to a resolution, it can easily fall aain. I hope O comes back sometime very soon, but I don`t see it this summer as I had hoped.
Maxdad believes everything will be resolved lickety split real quick. Think the Fresenius trial is good news? Let's see. According to SEC Form 3s filed, July 2, 2013, none of AFFY's officers own any of its shares. According to SEC Form 4 filed, June 28, 2013, former CEO and current Board Chairman, John Orwin, sold 16,334 AFFY shares for $1.02/share. AFFY's most recent 10Q, filed May 9, 2013, advises:
In order to address the safety concerns resulting in the recall of OMONTYS, Takeda would have to complete its ongoing thorough investigation, identify the causes of the serious allergic reactions and provide a suitable plan to the FDA for approval. We are unable to predict when or if this process may be completed or the associated costs, but WE EXPECT THAT THE INVESTIGATION MAY BE LENGTHY.
IF TAKEDA IS UNABLE TO IDENTIFY QUICKLY THE CAUSES OF THE OMONTYS SAFETY CONCERNS or [we are not able to] raise additional funds when required or on acceptable terms, we may have to:
• discontinue operations;
• relinquish some or all of our existing rights to OMONTYS milestones, royalties or other existing rights; or
• pursue alternatives such as sale of the Company or its assets, a corporate merger, winddown of operations or even bankruptcy proceedings.
Be advised. All is not smooth sailing for longs as Judas Sheep Maxdad would have you believe.
Max: I recall early on that Frens didn't have a means to test where the reactions were coming from, what they are referring to with the FDA in getting set up now? It seems like a protocol issue at Frens, not so much an O issue. Please correct me or expand on this if Im on track here.