Recent content by oya99

  1. O

    NurOwn stem cell phase 3 study

    Should have typed “not” compulsory...
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    NurOwn stem cell phase 3 study

    @par220 I have talked to someone at the Goldwater Institute (one of the major forces behind RTT) around the passing of the law, and they said that it is completely compulsory for both ends i.e. both the patient and the pharmaceutical company. Furthermore, the patient needs a recommending doctor...
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    NurOwn stem cell phase 3 study

    @par220 This review is standard procedure and does not speak to the efficacy of the procedure, only confirms that best practices are followed by an outside body (DSMB) as expected by the FDA. To be clear the following is my conjecture: What is new in this article is the information about the...
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    NurOwn stem cell phase 3 study

    Here is some recent news (07/02/2018 ): "In partnering with Dana-Farber for the manufacturing of NurOwn, BrainStorm has secured an additional facility to enhance production for the ongoing pivotal Phase 3 clinical trial, and to support manufacturing capacity for additional clinical indications...
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    NurOwn stem cell phase 3 study

    Both my husband who is a PALS and I are in academia, not in industry. I am sorry, I did not know all posting members needed to introduce themselves in a new post.
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    NurOwn stem cell phase 3 study

    I am not sure why what I wrote came across as insistence on PALS in US needing help with NurOwn payments. My post was a reply to @jethro who was worried about having the means to be able to afford it. I gave Searchlight as an example and said possibly such help may be available in the EU for...
  7. O

    NurOwn stem cell phase 3 study

    I meant that Searchlight has a provision for those that qualify to pick up either a portion or all of the Radicava costs. They certainly do not cover the costs for those who have insurance which agrees to payments or for those who can pay for Radicava through private funds. My point is that...
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    Again, I believe it is a big mistake to try to estimate a price for Radicava. Not a single...

    Again, I believe it is a big mistake to try to estimate a price for Radicava. Not a single person knows, including the CEO. They have not arranged a "production site" yet; so the cost cannot be estimated. However, the hospital and doctor cost of administering a bone marrow aspiration plus three...
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    NurOwn stem cell phase 3 study

    In US there is SearchLight to help with Radicava payments; it would not surprise me if another entity would help those who cannot afford it with NurOwn payments; if and when FDA approval comes along. Again, I am sure there are alternative payment help agencies/charities in EU to help pay with...
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    Below is the article link. In there you will find a link to the conference call. In the box on...

    Below is the article link. In there you will find a link to the conference call. In the box on the bottom, the link is next to where it says “Webcast”. You need to login providing your email etc. and then you should be able to listen to the whole conference call by Lebovits...
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    NurOwn stem cell phase 3 study

    I would like to correct a misunderstanding here; the cost of NurOwn is NOT estimated to be $300K. Earlier @Par220 posted an informative article which included the following quote: "Lebovits declined to estimate the cost for NurOwn beyond saying that cost of manufacturing and delivering the...
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    NurOwn stem cell phase 3 study

    I cannot imagine NurOwn treatment being cheap, Radicava's yearly price tag is $146K in the US (just the drug not including the infusion treatment part); and the discussion boards show how little data there are on its effectiveness. My guess (and that is only a guess) Brainstorm's treatment...
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    NurOwn stem cell phase 3 study

    Today the CEO emphasized that NurOwn is not a cure. The results are mixed at best, some patients see improvements, some see slow down, some others might not respond to this treatment based on Phase 2 results according to the Chief Medical Officer of Brainstorm. The CEO cautioned that people...
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    NurOwn stem cell phase 3 study

    @jethro You are correct, there are no trials in Israel. But this is because they are in treatment phase in Israel; so the trial period is behind them. Today Brainstorm's CEO had a 1.5 hour conference call which I listened to and he confirmed that NurOwn is in treatment phase in Israel. He also...
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    NurOwn stem cell phase 3 study

    @jethro I do not know the legal ramifications for Right to Try; but I do not see a patient being required to be US citizen. It is very new and not tested, but my "guess' is nationality of the patient is not going to be an issue. However, clinical trials are different, the pharmaceutical company...
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