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Member TLX 1 year ago #1

Am I the only one here?

Member NVAX 1 year ago #2

Didn’t mean to post 3 times sorry

Member NVAX 1 year ago #3

A Postmarketing Commitment (PMC) can take different amounts of time depending on what kind of data the FDA wants. If the FDA just wants Novavax to gather more real-world safety data or immune response info, the studies might only take 6 to 12 months. If the focus is on how the vaccine works in special groups (like older people or immunocompromised individuals), it could take 1 to 2 years. And if the FDA wants to track long-term safety or rare side effects, that kind of study can take 2 to 5 years.

Member NVAX 1 year ago #4

A Postmarketing Commitment (PMC) can take different amounts of time depending on what kind of data the FDA wants. If the FDA just wants Novavax to gather more real-world safety data or immune response info, the studies might only take 6 to 12 months. If the focus is on how the vaccine works in special groups (like older people or immunocompromised individuals), it could take 1 to 2 years. And if the FDA wants to track long-term safety or rare side effects, that kind of study can take 2 to 5 years.

Member NVAX 1 year ago #5

A Postmarketing Commitment (PMC) can take different amounts of time depending on what kind of data the FDA wants. If the FDA just wants Novavax to gather more real-world safety data or immune response info, the studies might only take 6 to 12 months. If the focus is on how the vaccine works in special groups (like older people or immunocompromised individuals), it could take 1 to 2 years. And if the FDA wants to track long-term safety or rare side effects, that kind of study can take 2 to 5 years.

Member NVAX 1 year ago #6

Gonna take a while by the sound of it.. ffs

The FDA has requested that Novavax commit to conducting additional post-marketing studies to gather more clinical data before granting full approval. The company has indicated that it is working closely with the FDA to address these requirements promptly .

The duration of these post-marketing studies can vary significantly depending on their scope and design. While some studies may be completed within a few months, others, especially those involving long-term follow-up, can take several years. The FDA requires sponsors to report annually on the progress of these studies .

In the meantime, Novavax’s vaccine remains available under Emergency Use Authorization (EUA) in the U.S. The company continues to collaborate with the FDA to fulfill the agency’s requirements and is optimistic about moving toward full approval as soon as possible .

Member IBRX 1 year ago #7

Is anyone watching the investors meeting?
This guy has basically said (but not saying due to fda approval) that it’s a cure for cancer!!
Don’t care about stock prices now, if this is true ! It’s gonna go massive when it’s passed.. just think cure for cancer! What’s bigger than that!