My fellow Tweeps had a lot to say about my story Thursday detailing a wrongful termination lawsuit that accuses MannKind ( MNKD) of covering up alleged data fraud in clinical trials of Afrezza, the company's inhaled insulin device. @rscalese tweets, "It is difficult to accept that Alfred Mann would risk so much after all the previous successes." Mann is the founder of MannKind, an entrepreneurial business legend and a billionaire. Many of MannKind's supporters believe in Afrezza's eventual approval because of Mann's stellar track record. I understand that, but I also know that everyone fails at some point. Isn't it smarter to look at each business venture -- MannKind, in this case -- on its own merits and forget about what Mann did or didn't do in the past? You only need to look at the recent past to find examples of highly regarded and successful business executives who fall from their lofty perch.
Sticking with Twitter but moving on to Exact Sciences ( EXAS), @goldsgymftl asks, "Riddle me this, EXAS has good news and the stock goes down, VVUS gets CRL and they bounce 30%????" Yes, it's the old expectations game. Exact Sciences shares fell a week ago Thursday after the company unveiled positive (but very much expected) results from an early study validating its non-invasive stool-based gene test for colon cancer. Skeptics argue that the stock dropped because the Cologuard data weren't as positive as one might have hoped. I recognize that the data leave some unanswered questions but were still positive overall. I think Exact Sciences' stock fell more because of the great run higher going into the data presentation. Once it was over, Exact faced two issues that turn off a lot of short-term traders: No more news for quite some time and the likelihood that the company would raise money.
@actionjack2000 is a big fan of Arena and he has a complaint: "$VVUS once it gets it's CRL, lets see if the media says 'rejected' in the headline like another recent obesity drug." Vivus did get its complete response letter from the FDA, which means the agency rejected Qnexa. The same thing happened to Arena's lorcaserin: The FDA rejected the drug. The Areniacs like to play semantical games because they still can't come to terms with the fact that they lost money with the stock. The FDA has two choices to make when it reviews new drugs. It can approve a new drug, or it can reject a new drug. That shouldn't be too hard to understand. A complete response letter, or CRL, is a rejection. A CRL doesn't mean that a drug will never be approved in the future, and in fact, many drugs handed CRLs the first time around come back to be approved later. It can take years and tons of new money to accomplish, but it does happen. Other drugs, of course, are never approved. Instead, the FDA just issues CRL after CRL after CRL. Areniacs have a lot more to worry about with lorcaserin than something silly like complaining about the use of "rejection."
@MedRepDad asks about Avanir Pharmaceuticals ( AVNR), "Do you think AVNR gets bought now? PFE, GSK, MRK???" No, I don't think Avanir will be acquired. I can't rule out the possibility entirely, of course, but the odds are low. Why? Because Avanir's newly approved Nuedexta has lousy intellectual property protection. Nuedexta is a combination of two approved but generic components -- dextromethorphan and quinidine. As a result, Avanir can only claim method of use patents on the drug as a treatment for the neurological disorder pseudobulbar affect. Method of use patents are relatively easy for generic filers to fight or circumvent, which reduces the net present value of the drug for any company kicking Avanir's tires and thinking about an acquisition.
Arthur K. writes, "I have been a holder of Spectrum Pharmaceuticals ( SPPI) coming on two years. I made some mistakes not selling but didn't expect Fusilev not being approved for an expanded label after FDA asked Spectrum to provide the drug on generic shortage. Now, there is a second second shortage. I'm concerned Spectrum will have to dilute again based on negative cash flow due to higher costs to build a sales network to sell drugs. Would you comment on this company based on current stock price and it's prospects with its pipeline and financial situation." I'm working with incomplete information since I didn't listen to Spectrum's conference call Thursday morning and the transcript isn't available as I type this Thursday night. With that said, I was encouraged by Zevalin sales of $7.7 million in the quarter, which puts the company within easy reach of its $27 million to $29 million sales guidance for the year. Moreover, the worrisome stagnation in Zevalin sales seen in the second quarter looks now to be one-time, Icelandic volcano-related issue. Fusilev sales of $6 million in the quarter were way higher than sales of just $300,000 in the year-ago quarter due to the current generic leucovorin shortage. I don't know how sustainable these sales are until Spectrum gets Fusilev approved for colon cancer, which could happen next year. Overall, I see reasons to be encouraged. Spectrum still loses money -- 9 cents a share in the September quarter -- but the cash burn is a manageable $2.5 million per quarter and the company has a lot of cash in the bank. The key to Spectrum's turnaround is Zevalin. It would be great to see the company break the $30 million sales mark for the year, which would essentially double sales from last year. Removing the onerous Bioscan requirement from Zevalin's label next year could fuel another jump in growth. --Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: firstname.lastname@example.org.