In the past many months, most Bio Firms have ad major run ups before PDUFA date but PPS droped significantly after the PDUFA date oneven on approval. The most recent example is ALXA, some other examples are HZNP, ARNA, VVUS etc.
Will PATH follow the recent trend? Unlikely IMHO. PATH has huge market potential upon approval. Per the rpesentation, at 5% market penetration, the patfch will generate more than $1 billion revenue.
($171 million for those vomit on every attack, $912 million for those vomit at least 50% of all the attacks).
PPS is about future value. A drug will $1 billion sales potential or more will make the firm worth at least $2 billion.
Those who are thinking "sell to the news" will be wrong unless PPS is at double digits.
NuPathe responded to the FDA concerns and resubmitted its application last summer. The company’s revised application included packaging improvements and the results from additional studies, one of which confirmed a safety feature of the product that stops the release of the drug if the patch is incorrectly applied.
Zecuity would become the first transdermal patch product approved for migraine headache treatment.
Migraines are severe and debilitating headaches characterized by intense throbbing or pulsing and often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraines afflict an estimated 36 million adults and children in the United States, and cost employers more than $13 billion each year in lost work days, according to the Migraine Research Foundation in New York. Decision Resources, a health-care research and consulting firm based in Massachusetts, recently predicted the market for migraine therapies will increase from $3.3 billion in 2011 to $5.8 billion in 2021 in the seven key markets: the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.