Heron (NASDAQ:HRTX) had a rough early May after receipt of a CRL for its HTX-011.
Cowen, however, has a possibly game-changing call this morning, says Notable Calls. The team there filed a FOIA request with the FDA to get more detail on HTX-011 rejection.
Bottom line, according to Cowen: The issues are largely procedural and resolvable with proper protocols, training, and employee oversight. Cowen expects resubmission in H2, allowing for a new PDUFA target date in early 2020.
Both the Sell-Side and SA authors remain bullish on Heron, with the SA Quant Rating is Very Bearish.
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