I TOLD YOU SO.
ATRS had no choice but to raise cash since they don't know if the FDA will approve the epi-pen. I dislike companies that raise cash at a lower share price then the previous raise. What a piece of junk.
ATRS/TEVA filed their response the first week of March. The FDA normally reviews a minor amendment within 30 - 60 days so that's why your seeing the May/7th date.
Crossject - developing injectors for Methotrexate, Epi, & Sumatriptan. Do you know any other companies with similar pipelines? I guess they're waiting for QSM to be announced.
The stock moved up to $3 as traders moved in ahead of the epi-pen approval & not due to some possible crumb falling from the TEVA/Mylan negotiations. Investors have bailed as its impossible to determine how the dispute will impact ATRS & no one needs the uncertainty in a weak biotech market.
Ginnypv, the ANDA approval for Sumatriptan was delayed & that didn't have the higher standards the epic-pen faces so anything can happen. The epi-pen is used for emergency situations so the FDA will delay approval if the pen doesn't work in the same manner as the comparator. ATRS/TEVA's pen can't be an exact working copy so what changes were made & would anyone find it confusing? We won't know this answer until we see a decision.
Did they mention anything about a potential launch timeframe for SO? Would JAZZ be able to block the approval or is this a completely new drug?
I don't see how Sodium Oxybate will be the story in 2016. They probably won't report data until late 2016 or early 2017.
"For Flamel, our objective is to meet with the FDA in the second quarter to discuss the pivotal trial program depending upon the outcome of that meeting we anticipate starting a pivotal trial in late 2015 and filing an NDA in the first half of 2017."
The problem with the stock price is the threat of West Ward or APP gaining approval for neostigmine. If management could give investors a timeframe then it would change the sentiment. I don't see how they can say anything more then predict no additional competitors for another year. What happens to the stock price in a year?
No. We are 100% Bloxiverz from Flamel. Fresenius is supposedly going to do a slow launch or doesn't intend to capture a large portion of the market in order to keep the price high.
The current response is to let looters burn down the city. Bunch of idiots.
whogo70 • Apr 22, 2015 10:10 PM Remove
I didn't get a chance to read the Seeking Alpha article today but now that I have the company almost looks like a scam. I've got small position & hope they don't report in the morning so I can sell.
Last thing I heard Matscum was pimping MEIP. I can't complain about the market eventhough the biotech sector is showing some weakness. As far as ATRS, the TEVA/Mylan saga has really screwed up the momentum.