Shire has no economic interest at all in midodrine any longer, but the company finally relented to FDA's demands last March. Had Shire refused, the company risked facing the wrath of patients for causing midodrine to be pulled off the market. A public relations disaster.
Why does this matter to Chelsea and Northera? The midodrine studies might show a greater symptomatic benefit than seen by Northera in its own study. Then again, midodrine might end up looking worse than Northera, which would be great for Chelsea.
One more twist: Given Shire's lack of financial interest in midodrine, the company may not disclose results from the two confirmatory studies when they finish up later this year. It's conceivable Shire just sends the data to FDA, as requested, without ever telling anyone about the results.
I'd focus more on Chelsea and the progress it makes toward the commercial launch of Northera later this year, rather than fixate on the Shire midodrine studies.
Shane S. asks:
Can you please stop wasting time writing an article responding to "hate mail" and actually answer a question that I've sent in 4 times now. Does the Feuerstein-Ratain rule apply to the upcoming phase 3 results for Oncogenex Pharmaceuticals' (OGXI - Get Report) custirsen in prostate cancer since they are partnered with Teva (TEVA)? Oncogenex has a market cap of only $170 million but Teva is a partner with a market cap of billions.Let's apply the Feuerstein-Ratain rule to Oncogenex and its prostate cancer drug custirsen. [An explanation of the F-R Rule can be read here.] Oncogenex announced on Feb. 11 the target number of deaths had been reached to analyze the phase III "Synergy" study. Oncogenex did not provide a timeline for when top-line results would be announced but I'm going to allow them 8 weeks to clean up the database and run the statistics. That puts the estimated date for Synergy study results on April 8. Four months back from April 8 is December 8, which puts Oncogenex's market cap at approximately $123 million. The custirsen phase III "Synergy" study will fail, according to the Feuerstein-Ratain Rule. The F-R Rule applies to the original holder of the drug and not the partner, if one exists. So, in this case, we look at Oncogenex's market cap, not Teva's. With that said, having a partner is a potentially positive mitigating factor because it implies someone conducted due diligence on the drug and liked what they saw enough to shell out money for a license. You'd think Oncogenex landing Teva as a partner for custirsen would have given the company some additional credibility with investors. Obviously, that hasn't happened, which may be an indictment of Teva's current difficulties. The company is not known for cancer drug development prowess. I'm still waiting for a drug to prove the fallibility of The Feuerstein-Ratain Rule. It hasn't happened yet. Most recently, Onconova Therapeutics (ONTX) fell victim. Last but not least, some leftover hate mail not included in yesterday's special Mailbag. Bryna W. sent me the following email, which appears to be cut and paste from an orthographically challenged message board post:
I am furious and I am consulting an attorney to see about suing Adam Feurstein. His definative and scathing pronouncement that Oramed Pharma's (ORMP) study data is "completely worthless" started a run to get rid of the stock, enticed two law firms to grab onto that info as the basis of law suits against Oramed and frightened hunreds of people like myself, small investors to dump their shares. I had just bought $50,000 in ORMP shares at $27.99 per and couldn't take a chance, based on his dire accusation, that the whole thing would collapse and I would lose it all. As soon as I heard this info and spoke to the law firm, I sold my shares at $16.50, a loss of almost $50,000! This at a time I was watching my account very carefully and not being careless as it was to be shortly used for purchase of a home. I have read other responses to AF's irresponsible accusations and they are from people who profess that he doesn't know what he's talking about when it comes to diabetes medications and trials. How can he be allowed to use his public pulpit to make such delarations without much more considered and careful research with those who know a hell of a lot more than a reporter on the stock market. Who wants to join me in considering a suit against Adam Feurstein?She was watching her account carefully because she needed the money to buy a home, yet she invested in an bulletin board stock pitching a dubious diabetes pill. You can't make this stuff up.
-- Reported by Adam Feuerstein. Follow Adam Feuerstein on Twitter.