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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
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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”
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IP runs through 2030. Another clown!
 






anonymous said:
Appreciate the intelligent perspective :)
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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.
 
























anonymous said:
EE and Nerd 2028 is my reading from their Nov. investor presentation. Sebela should be filing now, so launch in EE and NERD next year as well. That has me worried more than the IP.
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. NCE is not indication based. 2030 is current IP. Sebella has not made any progress getting a buyer to take over development and commercialization. I work at Braintree and it’s a shit show
 












It is actually sad to watch this place go down the drain with an excellent drug.

It’s the initial framework that is the downfall. The high focus on “erosive”, the lack of formulary coverage teams, cost saving instead of securing stronger RX analytics data, lack of pull through, budget cuts, budget allocation to dinners when prescribers don’t attend, lack of feedback from the field, keeping early RX data captive.

This drug is easy to sell & not complicated. There is no additional training necessary. The issues are larger, beyond the reps.
 






























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...
Citizens petition filed...odds are not good with historically <20% approval rate and can drag on for years. Do your math.
 






anonymous said:
It is actually sad to watch this place go down the drain with an excellent drug.

It’s the initial framework that is the downfall. The high focus on “erosive”, the lack of formulary coverage teams, cost saving instead of securing stronger RX analytics data, lack of pull through, budget cuts, budget allocation to dinners when prescribers don’t attend, lack of feedback from the field, keeping early RX data captive.

This drug is easy to sell & not complicated. There is no additional training necessary. The issues are larger, beyond the reps.
Click to expand...
So true.
 


















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