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Fennec Pharmaceuticals Ord Shs T.FRX

Alternate Symbol(s):  FENC

Fennec Pharmaceuticals Inc. is a commercial-stage biopharmaceutical company focused on its product candidate PEDMARK. It sells its product through a field force, including Regional Pediatric Oncology Specialists and medical science liaisons who are helping to educate the medical communities and patients about cisplatin induced ototoxicity and its programs supporting patient access to PEDMARK. PEDMARK is a Food and Drug Administration approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is a therapeutic agent with a dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6. It has established Fennec HEARS, a single source program designed to connect PEDMARK patients.


TSX:FRX - Post by User

Comment by fairweather1on May 24, 2013 10:32am
172 Views
Post# 21436637

RE: RE: FDA Meeting

RE: RE: FDA Meeting

looks like we have an answer:  FDA strongly recommends larger MBC trial; not one for rapid failures on xeloda.

 

The "market" is obviously not liking the press release, presumably because ahx doesn't have the resources to conduct said trial alone.

 

However, that is not to say the data has weakened.  So they will have approach it in a different way.  Wait for STS next move or find a partner, etc...

 

In the meantime, I still think if they can figure out why transitivity did not hold in the arm 1, 2, x comparison, a larger trial -- though more taxing -- will ultimately pay off in a bigger way, if there is a payoff.

 

By the way, I would like to hear the FDA's rationale for their recommendations.

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