Agreed, no point in arguing since there's no real way of knowing without either being a key insider or at the fda. We're entitled to our opinions though and we'll have to wait and see how it turns out.
Regarding the message board composition, don't you use the ignore button?
I don't want to argue with you on this. I like MNTA. I like the technology and the opportunity. I think the FDA will have to deal with the issues of an entirely new type of generic in the relatively near term. I do not think Sanofi can do squat about protecting Lovenox anymore, but they are not political heavyweights anyway and I was not referring to them in specific, rather to the efforts of other big hitters.
This was an interesting board, but the bull of inside info man and his alter egos has turned this into trash. I'll be watching MNTA from another vantage point.
You continue to misinterpret my posts. The filing is as a regular anda. There's no formal guidance for biologic generic approvals. There is guidance for nonbiologics which is what lovenox is considered by the fda.
If mnta has copied lovenox, exactly within allowable ranges, it would be hypocritical for the fda to not approve. That's why it's my belief there's only so far sanofi can go in politicking the fda on this.
And I realize mnta is going to have to educate the fda about their processes. Duh. But likewise I think it's presumptuous of you to assume that just because it's a new technology that means the fda will have trouble embracing or understanding it. I believe the opposite to be true. But like you say, I don't appreciate the science and like to deny facts.
Your claim that this is a regular ANDA is an indication that you do not fully appreciate the science. Even with MNTA's technology there is no way to characterize this the same way as a small molecule. This is a heterogenous mixture of complex carbohydrate chains. Yes, this is not a biologic in the sense that it is not a fermentation product produced by either mammalian or bacterial cells. But this is not a typical generic by any stretch of the imagination. This is a unique and precendent setting application.
As for Sanofi, I do not mean that their suit will prevail. Their conduct was inequitable and they have been punished for that. It is simply illustrative of the dozens of other suits that are regularly filed by branded companies to keep generics off the market.
Bottom line, there are no precedents for a generic version of a drug like Lovenox. As such, MNTA is paving the way. It makes for a more difficult trip. That is my sole point. If you are denying that it is only because you are in denial of the facts.
Lovenox is a regular anda, it's not considered a biologic. Sanofi can b&m all they want but the regulatory path is very clear. And the arguments they've been making against the other filers are fully addressed by mnta. So how will it look when they say, "yeah, but.."?
As far as biogenerics, no standards yet exist, which is why mnta is mum on strategy. If a biosimilar approach is adopted, then it probably will make little sense for mnta to pursue as their may not be much value for mnta to add.
Sorry guys, but if you don't think that AMGN,DNA, GENZ, BGEN and others are going to pull out all stops to get another month or another year of sales for their branded biologics you are being naive. I think generic biologics are inevitable, but it is not going to be easy to break through the wall. As for stopping generic drugs, you have to go back and remember that it took an act of congress to get rules established for the approval of small drug generics years ago. It may take similar action on biologic generics. Further, you can find dozens of lawsuits each year, like the Sanofi suit, attempting to stop generics from coming to market. There are $billions at risk for big bio and pharma here. If you think their primary focus is the well being of patients you are not paying attention.
I love MNTA. I have been long since May and continue to hold, but I have no illusions about the path ahead.
By the way, a poison pill only enhances the BOD ability to control buyouts. The fact that the company put in a poison pill means they do not want to bought out now. That is good. There is too much that would be left on the table at this time.
>>In other words, the stock goes up from here
I have been around to long to make short term calls.
MNTA should not, IMO, have sold under 22. But it did. It traded all the way down to 18.
Oxy, did you listen to the Rodman & Renshaw presentation?
Levonox is projected to do $3.5B* in sales in 2007, see slide 11.
Management suggests by analogy that gLevonox could do half* the unit sales at a 15% discount to Levonox pricing.
So what is gLevonox worth** if it does $1.5B in sales at a 15% discount to branded pricing? 2X, 4X, 6X sales?
What is M118 worth? Anyone notice the description of the early testing of it?
How many other drugs has MNTA characterized that are waiting for partners? What are they worth?
What are the 120 patents (pending) worth?
What is the platform worth?
What is the sum of these parts worth**?
Well today the market says the stock is worth $21 including $5.69 of cash, leaving a tech value of $15.33. Thus EV=$440M and MC=$603M.
Well maybe now those hyping idiots will realize I am not short. But I am not on crack either. :-)
* Seems a bit high to me.
** Sure we have to discount the value for failure and for time value.
Any friend of Sassy's is my friend as well. I think this stock has the potential of going well past 30 on news of partnership. Their blitz with the investment CC recently is not an accident it is well planned to get the stock into strong hands in preparation for various good news. MNTA also has another compound that they will submit a IND on in 2006, plus the M-Enoxaparin approval seems highly likely. There are legal matters with Sanofi-Aventis pending that can propel the stock.
Currently, the stock is trading at a significant discount to recent stock price with no negative news...