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EmilyGorcenski's profile
Emily G
Emily G
Emily G
Verified account
@EmilyGorcenski

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Emily GVerified account

@EmilyGorcenski

Lead Data Scientist, activist, survivor. Was actually assaulted by an actual right-wing terrorist. Opinions belong only to me, especially the bad ones. she/they

Deep Space Nine
emilygorcenski.com
Joined June 2013

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    1. ROGD = Zinnia Jones Gender Virus‏Verified account @ZJemptv 15 Aug 2016

      There's seriously no reason why there should ever be an estradiol shortage. Millions of cis women take it for many reasons, like menopause.

      3 replies 10 retweets 41 likes
    2. ROGD = Zinnia Jones Gender Virus‏Verified account @ZJemptv 15 Aug 2016
      Replying to @ZJemptv

      I don't understand how there can even be a shortage of "drug for half the population when they age".

      2 replies 4 retweets 22 likes
    3. ROGD = Zinnia Jones Gender Virus‏Verified account @ZJemptv 15 Aug 2016
      Replying to @ZJemptv

      http://www.fiercepharma.com/manufacturing/shortage-injected-hormone-falling-hard-transgender-women … Why would their supplier literally just *stop making it*

      2 replies 2 retweets 7 likes
    4. ROGD = Zinnia Jones Gender Virus‏Verified account @ZJemptv 15 Aug 2016
      Replying to @ZJemptv

      We need a long-term plan for reliable manufacturing of HRT drugs at high volumes in order to ensure immediate and continued access

      5 replies 5 retweets 19 likes
    5. Emily G‏Verified account @EmilyGorcenski 15 Aug 2016
      Replying to @ZJemptv

      So, I have a bit of FDA experience, mostly in medical devices, not pharma, but its similar....

      1 reply 1 retweet 1 like
    6. Emily G‏Verified account @EmilyGorcenski 15 Aug 2016
      Replying to @EmilyGorcenski @ZJemptv

      On 3/10, Par filed a notice with the FDA for a "manufacturing change or addition". They use contract manufacturers overseas, so...

      1 reply 1 retweet 1 like
      Emily G‏Verified account @EmilyGorcenski 15 Aug 2016
      Replying to @EmilyGorcenski @ZJemptv

      There is a good chance this is to change manufacturers or to modify the process in some way that isn't supposed to affect the drug

      9:43 AM - 15 Aug 2016
      • 1 Retweet
      • 2 Likes
      • M ROGD = Zinnia Jones Gender Virus
      1 reply 1 retweet 2 likes
        1. New conversation
        2. Emily G‏Verified account @EmilyGorcenski 15 Aug 2016
          Replying to @EmilyGorcenski @ZJemptv

          In a 2014 SEC filing, Par acknowledges the risk of mfg delays due to using overseas suppliers, so this couls be related.

          1 reply 1 retweet 0 likes
        3. Emily G‏Verified account @EmilyGorcenski 15 Aug 2016
          Replying to @EmilyGorcenski @ZJemptv

          *could. Anyhow, contract mfg is tricky because they're subject to FDA regulations. Hard to spin up a new one. Takes > 6 mos.

          1 reply 1 retweet 0 likes
        4. Emily G‏Verified account @EmilyGorcenski 15 Aug 2016
          Replying to @EmilyGorcenski @ZJemptv

          So the mfg is at least aware of the risks of single point of failure. Overseas mfg can be affected by stuff we don't hear about.

          2 replies 1 retweet 1 like
        5. Emily G‏Verified account @EmilyGorcenski 15 Aug 2016
          Replying to @EmilyGorcenski @ZJemptv

          FWIW, perrigo shut down their 20mg/mL dose to move up to 40. That should be available in 8-10 weeks.

          1 reply 1 retweet 1 like
        6. Emily G‏Verified account @EmilyGorcenski 15 Aug 2016
          Replying to @EmilyGorcenski @ZJemptv

          This is all public but hard to find. Just query 'delestrogen' at this database: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm …

          1 reply 1 retweet 2 likes
        7. ROGD = Zinnia Jones Gender Virus‏Verified account @ZJemptv 15 Aug 2016
          Replying to @EmilyGorcenski

          Would you be willing to like, maybe Skype at some point and we can do a little Gender Analysis interview about this?

          2 replies 0 retweets 0 likes
        8. ROGD = Zinnia Jones Gender Virus‏Verified account @ZJemptv 15 Aug 2016
          Replying to @ZJemptv @EmilyGorcenski

          This is a big thing for a lot of trans women and I feel like this inside look could help put people at ease

          0 replies 0 retweets 0 likes
        9. End of conversation

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