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Phathom

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A citizen's petition may be the most viable option. In my view, the FDA is unlikely to grant GAIN status to the 10/20mg. Currently, investing in the stock resembles a bet on litigation outcomes, reminiscent of numerous other biotech scenarios. A generic priced below $10 per day will undoubtedly outcompete PPIs, as evidenced by the situation in Japan. There lies a substantial market potential, and worth an at-risk launch by any of the Indian companies. The India license obviously does not include US rights but having a peek at the Japanese dossier is worth gold... just a matter of time.
 








anonymous said:
A citizen's petition may be the most viable option. In my view, the FDA is unlikely to grant GAIN status to the 10/20mg. Currently, investing in the stock resembles a bet on litigation outcomes, reminiscent of numerous other biotech scenarios. A generic priced below $10 per day will undoubtedly outcompete PPIs, as evidenced by the situation in Japan. There lies a substantial market potential, and worth an at-risk launch by any of the Indian companies. The India license obviously does not include US rights but having a peek at the Japanese dossier is worth gold... just a matter of time
Click to expand...
Appreciate the intelligent perspective :)
 




anonymous said:
Go ahead and show your proof.
Direct quote from the Orange Book is never wrong buddy .

“Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not.
FDA Orange Book Vonoprazan Exclusivity expiration dates:
  • November 1, 2026 - NEW PRODUCT
  • May 3, 2027 - NEW CHEMICAL ENTITY
  • July 17, 2027 - USE OF VONOPRAZAN FOR THE RELIEF OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE IN ADULTS”
Click to expand...
IP runs through 2030. Another clown!
 




anonymous said:
Appreciate the intelligent perspective :)
Click to expand...
The Japanese formulation has very high levels of nitrosamines. Which is why this launch was delayed for over a year. They would need to reformulate as Phathom had done. Recent investor presentation PHAT stated the reformulation was also under review for extended IP beyond 2030. So 2030 is the worst case scenario. But continue to spread fake news and fear amongst the sheep.
 












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