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I was lucky not to have a red thumb stuck in the hinges when the FDA kicked the door back open for Iluvien. I've practically given up trying to understand the FDA's thinking on this drug. My best guess is that there are strong, conflicting opinions within the FDA division in charge of Iluvien and different factions have the upper hand at different times. Nevertheless, with the PR that Alimera is now entering into "labeling discussions" with the FDA it would seem to be foolish to bet against approval. What I am betting against with this red thumb is that Iluvien is likely to have a highly restrictive label and will be a commercial failure in the US. Alimera has already struggled and spent tons of cash to steer Iluvien past regulatory agencies in individual European countries that made no secret of their disdain for the drug. The last quarterly sales in Europe were less than 1M despite the fact that the drug was approved by the EMA more than a year and a half ago. I expect US insurance companies to fight reimbursement tooth and nail as well.Alimera will be an interesting stock to follow over the next year as they head towards probable FDA approval of Iluvien. The spike on the announcement of the FDA action was excessive and driven in part by momentum traders, so expect the stock to settle below 4 before heading into a period of unpredictable volatility.
Short. Biopharma. $0 Revenues. Consistent share dilution.
This stock has been growing over the past few weeks. It seems that the growth is constant and should continue to grow over the next few weeks.
went up 244% for portefeille.
This is a huge need in Ophthalmology patient care. Patients are enduring numerous injections into the eye to decrease edema and the progressive damage it can create. This time-released med will last a long time while decreasing risk and cost to the patient.
There are currently 2200 ALIM shares in my "fund" with break-even of around 5.81 USD.http://caps.fool.com/Blogs/fund-trades/678775.
European approval will help lift it from the basement of FDA rejection!
Diabetes Diabetes Diabetes. americans are unhealthy
First FDA rejection was fairly benign. Investors will come back as second decision approaches.
oversold on FDA news
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