Saturday, May 10, 2014 11:50:50 AM
Wholesale price = gross price. Net price (before COGS): "our gross to net price adjustments include certain launch year-related factors, which resulted in a lower net price per capsule than the approximately $1.25 net price per capsule that we anticipate achieving over time." which is $150 and it's not include "higher costs for our intense co-pay card program"
One week number is not a number, so we have to see at least additional 2 weeks script number to see the trend and prepare some forecast for Q2. (My current expectation is: 95-100k script, 12,5M rev, 63% GP, 30M OPEX, (22,3)M OIL, (0,13) EPS)
Legal cases (for long-term prospective): NCE is not important, it's more PR/marketing IF (!) at least one relevant patent will exist. (Which I think is realistic). However we will not see any final ruling in any legal issue in the near future.
SPA / PDUFA: I still believe that FDA basis is not strong / not valid. The type of other drugs is not really relevant, however the characteristic of the population is that and the sub-group data prove the Vascepa’s science. If Hamburg does not want to deal with this issue, so maybe we get positive answer from Woodcock by October. (if Woodcock has the same attitude, iDr. Jenkins level will be reinstate the SPA by end of July) After SPA reinstatement ANCHOR will be approve since met all requirement and the department does not have choice.
I just wondering why we did not hear anything about label change: include ANCHOR trial data. I do not see any reason to refuse it by FDA since it is not approval. (Just like in case of Lovaza)
PPS: 1,50 is not good, however till it's above $1 it does not have any effect on the company itself.
One week number is not a number, so we have to see at least additional 2 weeks script number to see the trend and prepare some forecast for Q2. (My current expectation is: 95-100k script, 12,5M rev, 63% GP, 30M OPEX, (22,3)M OIL, (0,13) EPS)
Legal cases (for long-term prospective): NCE is not important, it's more PR/marketing IF (!) at least one relevant patent will exist. (Which I think is realistic). However we will not see any final ruling in any legal issue in the near future.
SPA / PDUFA: I still believe that FDA basis is not strong / not valid. The type of other drugs is not really relevant, however the characteristic of the population is that and the sub-group data prove the Vascepa’s science. If Hamburg does not want to deal with this issue, so maybe we get positive answer from Woodcock by October. (if Woodcock has the same attitude, iDr. Jenkins level will be reinstate the SPA by end of July) After SPA reinstatement ANCHOR will be approve since met all requirement and the department does not have choice.
I just wondering why we did not hear anything about label change: include ANCHOR trial data. I do not see any reason to refuse it by FDA since it is not approval. (Just like in case of Lovaza)
PPS: 1,50 is not good, however till it's above $1 it does not have any effect on the company itself.
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