FDA has informed the Company it has no plans to schedule an Advisory Committee Meeting
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!
This corporate update did not provide any clarity on what is happening. The stock is down right now.
It wont get approved in my opinion. My thoughts are on min 101. The kidney thing is big.
I suffer from negatives too.
What is the āKidney thingā?
Well, the truth is I donāt know/not sure. I just donāt think it will get FDA approval. Itās 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 donāt 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 wonāt get FDA approved? Iām assuming you must have reason to think that?
Ya, thatās what the company wants you to think because millions are at stake. The FDA is supposed to protect and help people.
Iām not for or against it anymore. Iām just stating MY opinion. I had a dream that was all. It was pretty real to me.
Iām more in the business of predicting things and putting it out here on the forums to show that I am indeed psychic. If Iām wrong, Iām wrong and Iām crazy. If not, maybe Iām 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 didnāt 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 Iāve been drinking them (several) every day for the past 15 years.
But my dream said lumateperone wonāt get FDA approval. Iām just sharing my thoughts. I donāt think Iām delusional about everything.
Iāve also had and died of cancer too. Iāve 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. Iāve 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. Iām not an expert and biology doesnāt interest me at all.
The topic of discussion is Lumeteperone, not creative ways to insult each other.
Down over 18%, the biotech bounces back.
What happened
The Food and Drug Administration told Intra-Cellular Therapies that it doesnāt plan to hold an advisory committee meeting to review Intra-Cellularās marketing application for lumateperone as a treatment of schizophrenia.
Thereās two ways to interpret that:
- The FDA thinks the meeting is a waste of time, because itās already planning on rejecting the drug and doesnāt think its outside advisors will be able to change the agencyās opinion.
- The agency doesnāt have any issues with the marketing application and is planning on approving the drug, so why waste its outside advisorsā time?
Investors seem to have had both opinions today, having sent shares down over 18%, only to bid them back up into the black.
The AdCom, i believe at first why they had a date for it on āāJuly 31āā, 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 āāFDAāā, they wont need a AdCom date. Independently can check these info.
Thatās what i think, but i can be wrong.
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 doesnāt mean some drugs canāt have long term effects that arenāt 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.