You say my time-frames are conjecture as if your predictions are more than conjecture. LMAO!
My time-frames are based on sound evidence.
No, I won't provide links.
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Sm04554 (samumed) Has Started Phase Iii
- Thread starter fuDHTck
- Start date
You say my time-frames are conjecture as if your predictions are more than conjecture. LMAO!
My time-frames are based on sound evidence.
No, I won't provide links.
Not necessarily. You're thinking it will be approved in Turkey first because you know the trials are in Turkey but the company can communicate its' info and data to the FDA rapidly today no matter where the trials are done. All of the info and data collected is on computers and they can print that info out in the USA just as fast as they can print it out in Turkey.
And if it proves to be effective and safe then it would hit the US market fast (likely within 6 months) so it wouldn't be much behind Turkey, if it's behind Turkey at all.
We're both making time-frame projections. Since you're also making time-frame projections about the drug does that mean YOU work at Samumed?
And I never said I worked at Samumed but I guess you couldn't comprehend that since I didn't limit myself to 1-syllable words in my previous posts.
Typical lack of intelligence. No wonder you're a conservative.
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What's even funnier is that you think your worthless conjecture has any value. As if I care what someone as dumb as you thinks. Check out the article below - conservatives aren't as smart as liberals.
https://theconversation.com/do-smar...oesnt-mean-all-conservatives-are-stupid-57713
And some posts back you said you weren't going to talk to me anymore. For a guy who isn't going to talk to me anymore you are sure are talking to me a lot. I'll get back to you after the general election when the winner is decided. Until then you're on IGNORE.
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Hi guys
No. I'm not homophobic at all.
I'm just trying to figure you out is all. You "liked" a previous post by me when I posted my time-frame projections and since you "liked' that post that means you supported my time-frame. And yet now you've gone all full-circle on me and you're supporting someone who impolitely took issue with my time-frame. I can't figure out if you changed your mind or if you're just doing some boot-licking on Pigeon? In any case, I don't like your inconsistency so you're on IGNORE.
Maybe you 2 are just drunk & bored so you guys decided to pick a fight. In any case, I'm moving on.
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The moon landing was a hoax
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Right! Since we can discount the gravity theory because the earth is flat, I think that's the only reasonable explanation left.
Because they might have to do another trial in order to be approved in the US while they don't for Turkey. They have not even had an end of phase 2 meeting with the FDA.
How can you be sure if Samumed has had an end of phase 2 meeting with the FDA? Does Samumed report that sort of stuff to you?
And even if Samumed hasn't had said meeting with the FDA does that mean it's impossible for Samumed and the FDA to have worked out these details without a formal in-person meeting. I find it hard to believe that Samumed would be conducting such a big phase 3 trial without the FDA being on board.
No but I read about it. You should try to do that too instead of claiming someone is wrong based on conjectures, buddy.
“Thank you for your question regarding SM04554 and the phase 2/3 trial being conducted in Turkey. Based on our pre-trial meeting with the Ministry of Health in Turkey, if the trial meets its primary endpoints, the data would support a marketing application in Turkey. Further, the trial also supports our IND with the FDA. We have not yet had an end-of-phase 2 meeting with the FDA. Based on the data from the trial, we would determine whether to have such a meeting to discuss with the agency what further data and trials would be necessary to support an NDA here in the United States.”
This is from september 2019 though.
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The guessing game is no fun with sources.
But seriously this side needs some kind protected threads with only approved infos.
Because this is the way a thread normally goes.
New info --> political, nazi or incell stuff --> a flood of missinformation because people think they are experts and their opinion has any value --> you can t find the real information again.
Your post is like the 5. or 6. usefull post in this thread and there are already 200 posts
1. You indicate that I've made some error by not coming across this info before. This is unwise thinking on your part since it implies that it's expected that everyone should have already come across literally ALL information that exists. This is the first I've come across the info you just posted, the same as you have and will come across info that's new to you throughout your life. This shouldn't have to be explained.
2. You yourself said that the info is old and it is. It's almost a year old. A lot can happen in a year so this info isn't reliable.
3. Your own evidence shows that Samumed has made their phase 3 study supportive of their FDA IND. This means that with or without a meeting, Samumed has ideas about what it needs to achieve. And Samumed didn't rule out the possibility that the FDA could say that the company has fulfilled its' requirements after the Turkey study is completed, although now that I've seen your posted info that outcome does seem less likely to me now. All that having been said, I'm still not 100% certain that the FDA will make Samumed do more studies.
4. Now that I've seen your posted info I'm less optimistic about this drug than I was before. The company says it may not seek FDA approval if the Turkey results don't justify seeking USFDA approval, which means that the company is unsure if it will continue to pursue FDA approval. The company is saying it won't know the answer to that question until the company sees the results of the Turkey study.
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new info --> political, nazi or incell stuff --> a flood of missinformation because people think they are experts and their opinion has any value --> you can t find the real information again. --> flamewar --> subject changes and now they're arguing about who started the flamewar (nameless makes a long dissertation, about why it was the other, not him)
If that's what you call a "Long" read I would stay away from books, including comic books, if I was you.
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Eh, okay, too long
Yea but for some people, reading a greeting card could be overwhelming.
And as an FYI, if we didn't make guesstimates and projections here we wouldn't have much to post about, but I guess you can't put that reality together in your head without help.
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If you say so