Schizophrenia.com

Intra-Cellular Therapies Provides Lumateperone Regulatory Update

http://www.globenewswire.com/news-release/2019/09/10/1913334/0/en/Intra-Cellular-Therapies-Provides-Lumateperone-Regulatory-Update.html

FDA has informed the Company it has no plans to schedule an Advisory Committee Meeting

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I asked my psychiatrist and psych nurse when if lumateperone would be available for uk patients, if it gets approval in September.

He had not heard of the drug or its trials.

I told them it is the next big thing in ap medicine, as it works differently to previous aps.

Sad that he had not heard of it!

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This corporate update did not provide any clarity on what is happening. The stock is down right now.

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It wont get approved in my opinion. My thoughts are on min 101. The kidney thing is big.

I suffer from negatives too.

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What is the “Kidney thing”?

Well, the truth is I don’t know/not sure. I just don’t think it will get FDA approval. It’s just a prediction/hunch. I know there is some issue with how it is metabolized in animals and how maybe it might be dangerous to humans.

I don’t think it metabolizes the same for animals if I remember correctly it was toxic to dogs but not humans.

And what makes you think it won’t get FDA approved? I’m assuming you must have reason to think that?

Ya, that’s what the company wants you to think because millions are at stake. The FDA is supposed to protect and help people.

I’m not for or against it anymore. I’m just stating MY opinion. I had a dream that was all. It was pretty real to me.

I’m more in the business of predicting things and putting it out here on the forums to show that I am indeed psychic. If I’m wrong, I’m wrong and I’m crazy. If not, maybe I’m not that crazy. Just my 2 cents.

Nobody believes in past lives (causal loops aka mental time travel) here. Anyways, I think I took it before (Lumateperone) and it didn’t end well despite it helping my psychosis a lot.

I was told in a past life at the mental hospital that I was going to die from kidney disease or something from energy drinks because I’ve been drinking them (several) every day for the past 15 years.

But my dream said lumateperone won’t get FDA approval. I’m just sharing my thoughts. I don’t think I’m delusional about everything.

I’ve also had and died of cancer too. I’ve died a lot and had a lot of things happen to me. I just want to help people. I think min-101 will get FDA approval and help people a lot. I’ve taken both.

Even if lumateperone gets FDA approval, which it could possibly do, it might have problems in the long run with organs and such. I’m not an expert and biology doesn’t interest me at all.

This post was flagged by the community and is temporarily hidden.

This post was flagged by the community and is temporarily hidden.

This post was flagged by the community and is temporarily hidden.

The topic of discussion is Lumeteperone, not creative ways to insult each other.

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Down over 18%, the biotech bounces back.

What happened

The Food and Drug Administration told Intra-Cellular Therapies that it doesn’t plan to hold an advisory committee meeting to review Intra-Cellular’s marketing application for lumateperone as a treatment of schizophrenia.

There’s two ways to interpret that:

  1. The FDA thinks the meeting is a waste of time, because it’s already planning on rejecting the drug and doesn’t think its outside advisors will be able to change the agency’s opinion.
  2. The agency doesn’t have any issues with the marketing application and is planning on approving the drug, so why waste its outside advisors’ time?

Investors seem to have had both opinions today, having sent shares down over 18%, only to bid them back up into the black.

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The AdCom, i believe at first why they had a date for it on ‘‘July 31’’, it was due that they didnt have the non-clinical trial files and wanted public expert to discuss about. Now that they have everything in hand the ‘‘FDA’’, they wont need a AdCom date. Independently can check these info.

That’s what i think, but i can be wrong.

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The thing is, if the FDA thinks the animal toxicity is relevant to humans, they are very late to the party with thousands of people now having taken Lumateperone, and some of the studies have had people on the medication for 6 months, maybe longer.

I dunno what they are doing, but you would think these metabolites they are worried about would have turned up in people if they were going to. Metabolites are the byproduct of the body breaking down a drug into a different substance - that starts happening right away when you take a drug, not months later. That doesn’t mean some drugs can’t have long term effects that aren’t recognized til later, but if the ill effect is related to the metabolite, well, you should be able to measure a metabolite right away.

IDK it is puzzling.

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