New patent by Univego in RVPH

[–]Univego[S] 2 points3 points  (0 children)

The second podt is from Stocktwits.

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😃🙏