PLX..$9.38 email correspondance from IR clarifying "blackbox" comment and other issues: (credible Twitter member otherwise I would not post this.)
gantosj wrote: As I promised, I sent email to the IR and here is the detailed questions and the answers in Blue
1. UBS mentioned a draft version of the taliglucerase label was posted on the Brazilian Ministry of Health website, which contains a black box warning and it further characterized the hypersensitivity reactions observed in the pivotal trial as anaphylactoid reactions. I need an urgent reply from Protalix...any refers from the management or insight please!!!!! The label posted by BOH is not the label the Company submitted to FDA or other regulatory agencies. The Company reported a rate of 6 percent hypersensitivity - no Serious Adverse Events.
2. I have not seen a single PR stating how the FDA has addressed the manufacturing issues that resulted in a delay of the PDUFA goal date and what was the company's reply... There was no issue. PLX provided a validation plan, but the FDA requested data from that plan, and not just the plan itself before moving forward. PLX submitted this data and the FDA accepted their filing.
3. It´s unclear why the FDA has not granted priority review to a fast-track drug, can you give me the reasons please Because there are two approved agents and no longer a shortage of drug in the U.S.
I hope this answers will help you guys in your trade Again...it's the same company and the same product that every one believed a month ago, it's the safest FDA play this year....the only thing changed...is the volatility and level of fear...that's exactly what some MM want you to feel keep going...and holding tight Joe
Anaphylactoid reactions will be a major problem for a drug that is competing against established products without such problems. Old label, new label...makes no difference if this protein has elicited anaphylactoid reactions due to its immunogenicity.
This is for drug that FDA has approved, and is manufactured by Shire. Look at page 7 at the end, and you'll see that Hypersensitivity reactions was occurring also, in 2 patients. Read farther in the document and you'll see that hypersensitivity is something that can happens in over protein drug.