The FDA rejection of NuPathe's migraine patch Zelrix on Tuesday pretty much puts the company out of business, at least from an investor standpoint. NuPathe's management handled the announcement of Zelrix's rejection poorly, which seems to be a recurring theme with these guys. No conference call to explain FDA's decision? A stock halt that started on Monday afternoon and only lifted with the release of NuPathe's press release on Tuesday morning? Really?
NuPathe has $36 million in the bank, burning about $2 million a month, and management suggested Tuesday in its canned announcement that it will seek to resubmit Zelrix to the FDA once it figures out why the migraine patch was rejected in the first place. Zelrix was going to be a super-niche product even if it had been approved, so the rejection and long wait for anything new to happen makes investing in NuPathe today a waste of time and energy.
Assume at least one year before any FDA resubmission, followed by another six-month review period. Meantime, migraine patients aren't going to miss wearing a drug patch the size of a dollar bill that offers slow pain relief even if it may cause less nausea than faster migraine remedies.
If daytraders want to kick the stock back and forth between each other, then I wish them the best of luck. Investors, on the other hand, should just move on to something else.HKF056 writes, "I was disappointed that you didn't even comment sarcastically when FDA cracked down on Cel-Sci (CVM). What happened?" Vacation happened. Sorry. FDA watchdogs sent Cel-Sci a warning letter last month accusing the company of making misleading statements on its Web site about its experimental cancer drug Multikine. "The Web pages contain claims that promote Multikine, an investigational new drug, as safe and effective for the purposes for which it is being investigated," FDA's letter states. These claims violate FDA law and are misleading statements "concerning from a public health perspective because it suggests Multikine is safe and effective when the product has not been approved by the FDA and the promotional claims made have not been demonstrated by substantial evidence or substantial clinical experience," FDA added.
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