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portefeuille (99.56)

ALIM

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3

March 09, 2011 – Comments (3)

It might be a good time to buy a few ALIM shares. ALIM shares are currently one of the larger positions of my "fund" (see here). There are currently 1300 ALIM shares in the fund with break-even of around $8.99. ALIM is at around $7.70 now.

 

zzlangerhans on ALIM.

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... Submitted: 1/13/2011 ...

Alimera has gotten low enough that I'll plant a flag here for eventual approval of Iluvien. Extended efficacy data and manufacturing deficiencies aren't likely to keep Iluvien from being approved the second time round, given the impressive two year efficacy that has already been demonstrated.If the share price drops below 9 I'll re-evaluate the stock for a potential GBMB buy.

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(from here)

 

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January 22, 2011 ...

Alimera (ALIM) – market cap 281M, share price 9. Cash 55M, debt 0, burn 6-8M/quarter. The stock wasn’t hit too badly on news of a CRL for Iluvien in diabetic macular edema last December 27, but the selling seems to have ramped up this past week. Given that the CRL seemed fairly benign, citing only some manufacturing deficiencies and the absence of three year data from the phase III FAME study, continued downward movement seems unjustified. Final three year data was collected last October, too late for the NDA submission, but perfectly timed for a quick resubmission. Once this data is fully analyzed and the manufacturing issues have been addressed, there’s an upside of 15 or higher should the drug be approved in late 2011 or early 2012. While the FDA always has the prerogative to raise new safety or efficacy concerns on a resubmission, the lack of a request for new clinical trials bodes very well for the next PDUFA. The all-time low for the stock of 6.6 came during this past summer of European discontent, and will almost certainly not be revisited prior to PDUFA #2. A couple of notes of concern: Iluvien licensee pSivida has seen a similar share price drop over the last week, indicating that the decline may be due to more than just short-term chaos. Short interest remains high at 16%, although I am unsure if this accounts for those who covered after the CRL. I bought 2000 shares for the GBMB account at 9, but I still advise caution until downward momentum has clearly ceased.

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(from here)

 

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Another of my recent trades is Alimera Sciences (Nasdaq: ALIM), who in December received a surprising Complete Response Letter from the FDA for the Iluvien ocular implant for diabetic macular edema. I saw the CRL as a "soft" rejection with no additional clinical trials required, but the effect of the rejection on the share price was proportionately mild. I took a position in CAPS to help me monitor the stock and waited, and eventually the share price degraded to the point where I felt a trade was warranted. I bought 2000 shares at 9 which almost immediately rose to 10.3. In 2010 I would likely have booked my profit, but since I left so much money on the table last year I decided to keep holding through the Iluvien resubmission. Subsequent extended data from the Iluvien clinical trial dropped the share price back down to 8.5, so the conclusion of this story is yet to be seen.

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(from here)

 

some company presentations are here.

3 Comments – Post Your Own

#1) On March 09, 2011 at 11:37 PM, portefeuille (99.56) wrote:

Subsequent extended data from the Iluvien clinical trial dropped the share price back down to 8.5

Alimera Announces Positive 36-Month Results From the Completed Phase 3 FAME(TM) Study of ILUVIEN(R) in Patients With Diabetic Macular Edema

 



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#2) On March 09, 2011 at 11:45 PM, portefeuille (99.56) wrote:

Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart.



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#3) On March 10, 2011 at 12:23 AM, GreenCollegeGrad (78.15) wrote:

sup port

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