In the first article that I wrote about PROTALIX early July I stated:
"I am confident that PROTALIX is close to the resubmission. I believe that the Company will be able to address all of the requests the FDA had asked for in their complete response approximately near the end of July until mid-August.
Today August 01st PROTALIX Submits Reply to FDA Complete Response Letter for Taliglucerase Alfa and Reports Top-Line Results from the Company's Switchover Trial.
The Company's submission addresses the issues identified by the FDA in the Complete Response Letter, including the request for clinical data from the Company's switchover trial and long-term extension trial, and additional information relating to chemistry, manufacturing and controls (CMC).
Data from all twenty six adult patients enrolled in the Company's switchover trial of patients switched from Cerezyme® to taliglucerase alfa over the nine-month period, were included in the submission. The data supports the efficacy and safety data package showing that patients can be switched from imiglucerase (Cerezyme®) to taliglucerase alfa. One patient experienced a hypersensitivity reaction. The efficacy data demonstrates that mean hemoglobin and platelet count, spleen volume and liver volume remained stable. Patients enrolled in the trial were switched from imiglucerase (doses ranging from around 10-60 U/kg every other week) to an equivalent dose using the same number of units of taliglucerase alfa.
The submission also included data from treatment naïve patients who completed the Company's pivotal Phase III trial and have continued to receive taliglucerase alfa for over 24 months in the Company's blinded long-term extension trial. These patients continued to show an improvement in efficacy and the drug was safe and well tolerated. Furthermore, those patients who were followed specifically for their bone parameters using Quantitative Chemical Shift Imaging
(QCSI) MRI continued to show bone marrow improvement over time. Detailed data from the Company's switchover trial and long-term extension trial will be presented at upcoming medical meetings.
Regarding CMC, Protalix submitted further analyses and modifications of analyses previously submitted to the FDA to address their questions raised with regard to testing specifications and assay validation.
After the resubmission completed, PROTALIX expects the FDA to provide an updated Prescription Drug User Fee Act (PDUFA) target action date within 14 days.
The FDA review team and division director will determine the classification of the
response, and a letter will be issued to the applicant acknowledging receipt of the
resubmission within 14 calendar days stating the classification of and the due date for action on the resubmission.
Class I is a two month review from the date of submissionClass II is a six month review from the date of submission
I anticipate that PROTALIX will get a Class II resubmission according to the data that was requested by FDA. If they receive a Class I resubmission, it may benefit shareholders significantly since there is less time to discount the event of possible approval.
I received so many emails and direct messages asking me, if PLX got Class-II, is it going to suffer a sell off too? The same as we usually see in the Biotech land these days.
I think that there will be no sell off, or a small action of profit taking, as most of the investors following PLX are a long term investors, and most of the biotech retail investors that usually following the catalyst run up, leave after it's done and jump to the second play, most of them already left the short term trade during the market volatility and shake out waiting for the debt ceiling issue to be solved.
As most of these investors already know that most likely Protalix will get Class-II review, so will be no surprise at all, and only the investors that believe on Protalix's potential will keep holding, knowing that beside the FDA review there is the European and the Brazilian review too, both are a real catalyst by themselves.
I will keep holding PLX through the decision, and wait till the PDUFA date, Technically we can see a solid support around $6.20, and if there will be a profit taking, I don't think that the price will break out this support level, in the other side, we know that Protalix can run up very fast to the $10 - $11 levels, as already did last year, and the resubmission is much safer than the first PDUFA and PLX most likely get the FDA approval.
Disclosure: Long PLX