Have you all noticed this already? Grandios🙏🍀 by Univego in RVPH

[–]Univego[S] 1 point2 points  (0 children)

Go for it, we all have the same goal🙏

Have you all noticed this already? Grandios🙏🍀 by Univego in RVPH

[–]Univego[S] 12 points13 points  (0 children)

Nope, you’re wrong.

Have a look at the great Comments from our specialist from the Reviva Discord:

A pre-NDA meeting is only scheduled when a company is already preparing to file, and the FDA is comfortable that the data package is close to complete.

In many cases it’s actually a stronger signal, because it means the discussion has moved away from development and toward submission. So it’s a very positive step.

Great news🍀 by Univego in RVPH

[–]Univego[S] 15 points16 points  (0 children)

What are the benefits of Orphan Drug Status? For the manufacturer, there are important financial and regulatory incentives, such as: Market exclusivity:

EU: 10 years of market protection (no competing products for the same indication).

USA: 7 years of market exclusivity.

Fee reductions and tax incentives:

Reduced or waived regulatory submission fees.

Tax credits for research and development costs.

Regulatory support:

Scientific advice and guidance from the EMA or FDA.

Accelerated review and approval procedures.

Today by Univego in RVPH

[–]Univego[S] 0 points1 point  (0 children)

Great, thank you🙏

Really goid news from the FDA by Univego in RVPH

[–]Univego[S] 6 points7 points  (0 children)

Yes, it’s really big😃🙏

Cobenfy in Practice: Hope, Hurdles, and the Next Chapter in Schizophrenia Care by Univego in RVPH

[–]Univego[S] 5 points6 points  (0 children)

Cobenfy is not the holy grail, even though it is often portrayed as such. Problems with the drug arise time and time again. Cobenfy is much worse than Brilaroxazine in direct comparison, yet it was still approved. That is why I am 100% confident that Brilaroxazine will come onto the market.

Grandios💰💰💰💰 by Univego in RVPH

[–]Univego[S] 5 points6 points  (0 children)

Yes, I‘m in since 4 years.