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pSivida Corp. Message Board

  • lucifertrader lucifertrader Oct 8, 2013 4:31 PM Flag

    FDA will not approve the drug failed two times and trying the third time

    THIRD FAILURE OCT 17, 2013
    The news will read out like this ... shares of ALIM and PSDV get crushed 90% ............

    Second Failure Nov 11, 2011
    Shares of Alimera Sciences (ALIM -72%) are crushed after the FDA fails to approve its Iluvien drug for the treatment of diabetic macular edema, stating that the risks of adverse reactions were "significant." Alimera will need to conduct two additional clinical trials to demonstrate that the product is safe and effective. Shares of Iluvien licensee pSivida (PSDV -54%) also sink.

    First Time DEC 27 , 2010
    Alimera (ALIM) fell 29% in Thursday's AH trading after the FDA failed to approve its Iluvien drug and asked for more info, but Oppenheimer sees the weakness as a buying opportunity and expects Iluvien to eventually be approved.

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    • Lucifer since you are the expert short the stock and get back with board on the 17th. Based on your bashing I doubled my position yesterday.

      Sentiment: Hold

    • Be fearful when others are greedy. Be greedy when others are fearful."

      That's why I bought 6100 yesterday. Anyway, silver wound is not mortal then even if something goes wrong, we patienterons PSDV as a pipeline that brings money already

      Sentiment: Hold


    • So what has Adam F had to say about this?

    • I think the UK, German and French approvals show that the way they are filing now will likely result in FDA approval

    • I don't know what the outcome will be. My understanding is that this time they are positioning the drug as a last resort i.e. after other standard treatment methods have failed. As long as the patients and doctors know the risks, why not place the decision in their hands?- as long as there is some reasonable possibility of a good outcome when other options have been exhausted. If FDA thinks in this fashion, I think they got a shot at approval. Note that PSDV raised money awhile back. They could have waited until after decision when stock price would be higher, but they took a conservative route. They don't know what is going to happen either. Money is money, -but for people buying in now they are risking their investment. For me, I got in at a buck and change, so I'm playing with houses' money. Long term, as others have pointed out, the Tethadur platform offers even greater opportunity than LLuvien. If I did not have a lot of short term profit in the stock {and have to owe taxes on the sale}, personally I would not be buying now as new investor. I'd be waiting on sidelines until after the 17th and then choose whether to honest two cents...GLTA

    • ddeboy Oct 8, 2013 4:38 PM Flag

      then short the daylights out of it and cry in 1 week.

    • You know little about anything going on in this company. It's not about Ilvien, it's about Tethadur. He who possesses this platform delivery system, owns biologic delivery for the next 10 years.

    • So what are the odds of an approval for Iluvien, which has previously received two complete response letters from the FDA? In the last CRL, the FDA asked Alimera to conduct two new phase III trials which would be extremely expensive and could take three to four years to complete. Alimera believed that the information that the FDA needed to approve Iluvien could be provided from the data already compiled for the previous NDA filings. Alimera hired a consulting company to reorganize the NDA paying them $4 million and potentially another $2 million upon approval. Encouragingly, the FDA accepted the refiling and set the October 17th PDUFA date. This along with the previous approval of Iluvien in seven European countries suggests that there is a reasonable chance for approval.

      I place the upside as potentially $9 to $13 with Iluvien's approval and $2.25 to $2.50 if it is not approved. I place the odds for approval as better than 60%. The approval by European regulatory agencies indicates to me that there is a persuasive case for approval based on the data in the NDA. I am inclined to think that the format of the initial NDA filing was flawed and with a better presentation of the underlying data that the US may follow Europe in approving Iluvien. I want to caution investors that these are guesses on my part meant to convey magnitude of the potential upside and downside. They convey more precision than is actually the case. Based on this reasoning, I think that the potential upside in the case of approval substantially offsets the downside if Iluvien is rejected.

      Sentiment: Strong Buy

3.45-0.11(-3.09%)Apr 17 3:59 PMEDT

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