$MYL falls 15% as Wall Street reacts to ~92% premium paid in $7.2bn $MEDAA deal and disappointing sales of top-selling product EpiPen.
TEVA has 2 filings on EPI, I know one is for an AB rated product and the other I did not know what it was for but someone mentioned it is for a BX. I did not fact check it because Heather mentioned MYLAN expects a BX rated EPI in 2H this year, and has always believed the AB rating would be extremely difficult to achieve.
For the BX rating, who else could Heather be talking about?
As for the CRL, TEVA said it expected it in December and then ATRS mentioned in back to back investor conferences that TEVA said it was coming and it never came. TEVA also mentioned being in constant communication with the FDA-- tell me how it is possible TEVA could expect a CRL and be in touch w/ the FDA but it not be received? Perhaps a 'formal CRL' has not been received, but I believe TEVA is aware of the hold-up and whatever needs to be done is being worked on. However, I think the BX rated application (if that is what it was for) would likely be the first to get approved and to follow would be the AB rated product after all the kinks are ironed out. There is speculation here, but its logical. We will know the truth when we know.
If anyone else has any other ideas, please share them...
At least two different posters have said that Teva filed two applications, presumably BX and AB. I don't know the source of their information, but it seems plausible. Teva has never said they were certain of AB.
How many Mylan shares are Teva still trying to dispose off?
Would you send a message to the market that can put a major dent in the price of the shares you are trying to get rid off? Unless you have to.
If the would have received info that would have nixed an A/B rated EPI surely they would have had to inform the market about that.
Interesting endless speculation about something that did not exist, the last couple of weeks...
The FDA asks questions to every company that provides any part of the manufacturing of a drug. Its just part of the review.
You have I dont know how many posts about a EPI BX in 2016. Where is the Filing? There would have to be an NDA for that I think. Where does this BX thing come from? From the same source as the non existent CRL that we have had a gassilion posts about ? Not to mention what this CRL has had in it. Icantrade/Whogo you are free to speculate now whats in the letter that is not in existence(I asked many times(where is the confirmation that Teva has received a CRL)about the source of this letter having been received.
They may have wanted some information from Antares to aid them in their response to Teva. They are, after all, partners. But if there is a CRL, which seems likely, Teva will get it, not Antares.
This is why I got stopped in ACAD at 20.5 (and bought another starter at 16.7)
If you listen to MYL conference, they said volume went up 10% but prices actually went down (pressure on pricing).
Don't know if globally only or also US, but there will be pricing pressure under current environment.
They received questions from the FDA and they are currently formulating a response - look in the last presentation on their website. Il they receive questions is that not equal to a CRL?
The FDA must be under some pressure, given the price raises on EpiPen which are beginning to attract notice, to resolve this in some way which makes a generic possible.
Hey batter, the PPS may go lower but I bought more at .90 based on all the information I heard from MYLAN and lack there of from TEVA. I viewed the EPI situation as a 'positive bias' at .90 cents.
Yes, I didn't say it was bad news. I think the no news is decent news, but if you think EPI (AB) is needed in 2016 to turn the tide then you didn't hear what you needed to hear. If you think EPI (BX) in 2016 will turn the tide, then you may have gotten that from Heather and TEVA's lip shut.
They said they had an action date from the FDA in December, that date came and went. They said they had told investors that they had expected a CRL because they were not far enough along in the process for approval. They said they are in weekly contact with the FDA and still expect a CRL.
The fact that they are in weekly contact with the FDA leads me to believe they are getting closer to resolution. Atleast there was no bad news.