Sounds like the QST NDA and the Amag sNDA will be filed pretty close to each other. Definitely something to look forward to!
Agreed and there is another AB rated that is not the same.
This is why I'm thinking it might be related to Emergency response medication and not other type.
loko, sorry I didn't look into Amag-Makena. I am fixated on the EPI story because it is directly related to what the chart pattern is doing. I am all for the goodies, but not until we break the downtrend and I think tomorrow is make it or break it time. EPI (BX) w/ future prospect of EPI (AB) still on the table will be well received by the ATRS community. I hope this is what we hear tomorrow. Either ATRS to the moon, or me-- I prefer ATRS goes first.
If TEVA says it expects EPI BX approval in 2H and the EPI AB timetable is uncertain because certain things need to be looked into then EPI AB remains uncertain w/ prospect of potential future while we get a boost from EPI BX being likely in 2H since MYLAN CEO said she expects this and is built into their model.
Sounds good, but AB remains uncertain. Maybe tomorrow will bring more clarity. The only thing wrong with cache's theory is that it's hard to believe it took more than half a decade for the FDA to make such a simple decision.
An even better outcome for ATRS, I meant to say, I think TEVA was going to get 60% w/ EPI (AB) eventually but w/ the EPI BX in 2016 w/ prospect of EPI AB in 2017 it works out very well for ATRS-- IMO. I hope this is what we come to find is going on. I thought SUMA was getting the BABE off ATRS back, but evidently its the EPI approval of BX or AB or both that needs to get rid of the BABE. Lets here the news already!!!
Thanks for calling the Amag presentation to our attention...I listened to the Antares part..it actually made me feel pretty good...will be observing more closely the progress towards the sNDA.
I have a thought, can TEVA go for the BX approval in 2016 (application 2) and continue its pursuit for the AB rated approve (application 1) for what would appear to be in 2017 or later? I would think if TEVA gets EPI BX in 2016 and then gets EPI AB in 2017, they may garner 60% of the the EPI market between the 2. This would be an ever better outcome then just EPI (AB) in the years ahead. Thoughts?
tanks 4 da only reply nyweatherfan.......but it had nothing to do with the epipen....oh well.....as if anything matters at this point...what a dung heap......maybe someone could tell Jack about the Amag partnership.....Tell'em Amag is talking about the deal...so maybe just maybe, they would not complain if he put out a good upbeat PR, for a change............naw why would they want to do dat....
Amag Q4 CC is next week weds....should hear more on the deal.....some one tell Jack to listen in........
well since it was mentioned in an Makena post..... guess we will see what cheap master Teva has to say on the Epi tomorrow....Mylan had a lot to say during their CC...but nothing on Teva.........then again...it's ninety cents......nothing really matters at this point.......
I've learned tonight that Teva has filed applications for both AB and BX, and that Antares stands to benefit significantly even if it is BX. Epi BX and Suma would probably alleviate anxiety over further dilution, a big plus. Nothing wrong with 10 to 20 percent market share. A good day for the Antares Message Board, too.
Explain to me why holding a Teva EPi in your right hand, you would read the Mylan instructions in your left had to do the injection. Is Teva going to ship their EPI with Mylan instructions to save on printing cost?
Did your Ford come with a Toyota manual in the glove box?
But cache was referencing the need for the operating directions to be the same for an AB rating. He was not referring to the issue of minorr differences.
It was actually there where the FDA said to Mylan"" Hang on your second generation injector is not the same as your first generation injector so what is your problem with a slightly different injector"" Not exactly using those words. As for the exactly the same they pointed out that patents would make that impossible and a requirement of Exactly the same would mean you cant have an A/B rated product that uses hardware.
If cache is right, there's no excuse for the FDA's letting this drag on so long. If he's right, they're just totally incompetent.
Where did the FDA stated that injector don't have to be the same ?
It might have been for other drugs that are not used in emergency situations.
Loko must have deleted his post but you can listen by going to the Amag home site. Under the investors tab click on events and look for the healthcare conference dated Feb 10th. You have to register and then you can listen to the presentation. Amag certainly seems to have a lot going for them and they speak highly of Antares. They were asked why they chose Antares. They stated there was not many products available that could handle such a viscous product and they were confident they chose the best possible partner (Antares).