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News Focus
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seekinganswers

01/05/26 12:42 PM

#807064 RE: underpar71 #807061

WRONG.
CHM is where apps go to die. and... it doesn't need to be disclosed because it's internal and not officially rejected yet.
Also, your fearless CEO already said she wont release any info until a FINAL decision is made. That hasn't happened yet, she will likely appeal and drag you out for another 6 months.
PS it's not new or novel, it's due to a failed P III trial and an antiquated tech.
JMHO,... good luck.
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AllSheWrote

01/05/26 1:42 PM

#807082 RE: underpar71 #807061

if it was a referral for denial, it would need to be disclosed


False. And even if true, when has the CEO ever thought she needed to disclose anything? Remember the 2015 efficacy IA? When did we find out about that? Oh, right, in 2024.
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learningcurve2020

01/05/26 1:52 PM

#807088 RE: underpar71 #807061

Still waiting for anyone to dig up anything that might resemble what $consultants$ are allegedly telling her?

>>What is noteworthy, and I would say this is based on what our UK advisors have said to us, we don’t have firsthand knowledge, but our advisors have said that there are quite a number of other companies who are in the situation that we’re in and are very long into the application process, can be as much as two years like we are. It’s not just us. That is a comfort factor, and it was helpful to hear that from our advisors. I don’t have firsthand knowledge, but they’re experts and they see the landscape.