Sm04554 (samumed) Has Started Phase Iii

MrJolly26

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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.

So, what do we get from this email, @Tom4362 ? Honestly, I don´t understand that.

Can anybody explain it? Does it mean that Samumed won´t release this product late 2021/early 2022?

Is it that?

Thanks =)
 

nameless2

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So, what do we get from this email, @Tom4362 ? Honestly, I don´t understand that.

Can anybody explain it? Does it mean that Samumed won´t release this product late 2021/early 2022?

Is it that?

Thanks =)

I agree with you. The email is unclear about key issues. For example:

1. The email is almost 1 year old so things could have changed since the email was written.

2. The email does not specifically state that the FDA will require more studies. The email indicates that the company may touch base with the FDA (if the Turkey study results warrant doing so) to see what, *if anything*, the company still needs to do.

3. The email does say that Samumed is doing its' Turkey study in a manner that will support an eventual FDA approval.

4. The email says that the Turkey results with SM04554 might not be good enough to move forward with seeking FDA approval.
 
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jared garnith

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Kane seems to be selling this now but I hear his purity lately has been very low, shame about alibaba too
 
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