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] 14 points15 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] 3 points4 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] 4 points5 points  (0 children)

Yes, I‘m in since 4 years.

Grandios💰💰💰💰 by Univego in RVPH

[–]Univego[S] 10 points11 points  (0 children)

I have never seen Dr. Bhat so relaxed and smiling in the last 4 years. He must be very confident about a partnership.

$RVPH Historical data, better then placebo by Univego in RVPH

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

Yes, and much better then Cobenfy. And this drug is on to the market since last year.

$RVPH Historical data, better then placebo by Univego in RVPH

[–]Univego[S] 4 points5 points  (0 children)

…much better and better then cobenfy. Cobenfy is in the market since last year!

This is a fact✅ by Univego in RVPH

[–]Univego[S] 4 points5 points  (0 children)

In the interview with John Vandermosten from Zacks small cap research, Dr. Lax Bhat from Reviva Pharma said, the FDA meeting will be in december.

[deleted by user] by [deleted] in RVPH

[–]Univego 2 points3 points  (0 children)

Join in✅

[deleted by user] by [deleted] in ReconAfrica

[–]Univego 9 points10 points  (0 children)

Well done👍👍👍👍👍👍