I posted the comment under my previous blog entry and want to make sure that others have a chance to read this.
Doctors and their patients should have the choice to decide for themselves.
In the most recent Phase 3 study, SPPI's Fusilev (levoleucovorin) was shown to provide colorectal cancer patients with less toxicity. The difference between Fusilev and racemic or generic leucovorin was statistically significant.
While both Fusilev and generic leucovorin are taken by colorectal cancer patients to prolong survival, the primary function of the two drugs is to decrease or mitigate the effects of toxicity from chemotherapy.
Since the objective of both drugs is to reduce toxicity and that Fusilev offers patients an alternative with a superior risk profile or less toxicity as evidenced by most recent Phase 3 data, then Fusilev should be approved.
PROVIDE PATIENTS WITH MORE CHOICES
- With their treating physician's help, patients should first be educated about their options and second allowed to decide which drug they would prefer (Fusilev or generic). The federal government via the FDA needs to keep out of the process.
ALLOW COMPETITION: EXISTING TREATMENTS
- Fusilev should not be prevented to compete with generic leucovorin. Here, the federal government looks as if they now may be trying to control healthcare costs through the FDA by limiting the approval of a safe and effective alternative. The FDA is destroying the value of small cap drug makers. The small American companies provide real competition to big pharma. Competition in this sector should NOT be limited or prevented by the FDA as competition, namely in the US, is responsible for improving healthcare for patients worldwide.
ALLOW COMPETITION: BETWEEN OTHER DRUG MAKERS
- SPPI should be allowed to compete with other drug makers such as TEVA in order to market a safer (statistically significant) alternative to oncologists.
Disclosure: Long SPPI.
Note: Since I began writing at SA on June 12, 2009, I have not sold any portion of my long positions in SPPI. Smart investors will hedge all of their long positions with put options in order to mitigate risk of loss.
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