Traders Eye Discovery Laboratories (DSCO) Ahead of March 6 PDUFA Date, FDATracker Sees Issues
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Price: $24.80 --0%
Rating Summary:
4 Buy, 0 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 10 | Down: 16 | New: 19
Rating Summary:
4 Buy, 0 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 10 | Down: 16 | New: 19
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Biotech traders have their eye on Discovery Laboratories (Nasdaq: DSCO) ahead of next week's FDA PDUFA date on Tuesday, March 6 for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Volume today is already matching the 3 month average.
The FDA classified the review of the Complete Response as a Class 2 review. If approved, SURFAXIN would represent the first synthetic, peptide-containing surfactant for use in neonatal medicine and provide healthcare practitioners with a potential alternative to the currently approved, animal-derived surfactants that today are the standard of care to manage RDS in premature infants.
FDA Tracker for one doesn't think the drug gets approved, saying Discovery Labs won't be able to demonstrate bioequivalence since it changed the formulation.
FDA Tracker concluded:
The high variance inherent in whole-animal biological activity test assays will prevent DSCO from meeting established inhaled albuterol bioequivalence standards when assay agreement is examined in a Bland-Altman plot. This is purely a statistical problem due to the nature of the assay – DSCO’s next option moving forward is to conduct a clinical trial using the new formulation and demonstrate consistency in the clinical outcome as the FDA originally requested.
We have no doubt Surfaxin works. We would approve it based on common sense because it appears to be effective and safe from the clinical trials. If DSCO had stuck with their phase III formulation, they probably would have been approved a long time ago. But because DSCO changed the formulation, they have to conduct an unprecedented bioequivalance trial for a surfactant delivered by lung lavage. DSCO entered uncharted regulatory territory, where they became stuck between a rock and a statistical hard place – a nightmare scenario for any company seeking drug approval.
The FDA classified the review of the Complete Response as a Class 2 review. If approved, SURFAXIN would represent the first synthetic, peptide-containing surfactant for use in neonatal medicine and provide healthcare practitioners with a potential alternative to the currently approved, animal-derived surfactants that today are the standard of care to manage RDS in premature infants.
FDA Tracker for one doesn't think the drug gets approved, saying Discovery Labs won't be able to demonstrate bioequivalence since it changed the formulation.
FDA Tracker concluded:
The high variance inherent in whole-animal biological activity test assays will prevent DSCO from meeting established inhaled albuterol bioequivalence standards when assay agreement is examined in a Bland-Altman plot. This is purely a statistical problem due to the nature of the assay – DSCO’s next option moving forward is to conduct a clinical trial using the new formulation and demonstrate consistency in the clinical outcome as the FDA originally requested.
We have no doubt Surfaxin works. We would approve it based on common sense because it appears to be effective and safe from the clinical trials. If DSCO had stuck with their phase III formulation, they probably would have been approved a long time ago. But because DSCO changed the formulation, they have to conduct an unprecedented bioequivalance trial for a surfactant delivered by lung lavage. DSCO entered uncharted regulatory territory, where they became stuck between a rock and a statistical hard place – a nightmare scenario for any company seeking drug approval.
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