For those of you who enjoyed the PPS runup to this decision date, lock in those profits and be safe. My view is that FDA is not going to approve this drug. Story hasn't changed much since last time around when I posted extensively on PLX. UPLYSO has atypical glycosylation given its produced in plant cells. They have inadequate clinical trial data to show that this protein is safe and does not cause hypersensitivity in a large sample of patients. FDA is not going to approve a novel expression system based on plant cells without extensive clinical data. Even a leading venture backed company such as Momenta had to jump through hoops for years until FDA approved their heparin bioequivalent. PLX is a shady company based in Israel and FDA will not approve them.
Permit me to repeat myself: You can make your investment decision based on information provided by Protalix, Pfizer, known financial analysts, and the FDA, or you can bet your money based on the undocumented ramblings of some anonymous message board posters. ... The choice is yours.
Pretty simple choice here: You can make your investment decision based on information provided by Protalix, Pfizer, known financial analysts, and the FDA, or you can bet your money based on the ramblings of some anonymous message board poster. ... Good luck to all.
Read my message dated September 18, 2011 "Anaphylaxis & Black Box for taliglucerase". This is the issue for approval. PLX gets either a Approval with Black Box for Anaphylaxis and restrictions on use as would apply to counter anaphylaxis.
A CRL is also possible a noted here.
there were "No anti-taliglucerase antibodies detected in the patients who experieced hypersensitivity" from from zimran, et al; BLOOD, September 6, 2011.
think about what this means b/f you jump to conclusion.
Regarding hypersensitivity, one patient experienced an immediate reaction after infusion of < 5 mL of drug and was excluded from the intention-to-treat efficacy population: predose serum IgE levels were elevated. This patient was subsequently identified as sensitive to imiglucerase as well. The inclusion criterion of a negative Ab test (to imiglucerase) was only for patients who had received imiglucerase in the past; therefore we did not test for presence of IgG Abs to imiglucerase in this patient at screening.
The FDA approves innovative drugs all the time. So, if saying the FDA will not approve because the technology is too new or not made in America is not stupid, what is? The guy is a clown and belongs in a circus.