Protalix is NOT using FDA designations to their full advantage. Protalix might try to apply for FDA Fast Track designation. Protalix's previous drug, Elelyso, got FDA Fast Track, and FDA Orphan. Also, where is Orphan Drug Designation for PRX-102. Should have applied for Orphan Drug Designation way back when PRX-102 was in Phase 1, since most of clinical trials are in the United States and would have counted towards United States Orphan Drug Tax Credits. Like I wrote before, the tax credits are not retroactive and only start after granted the FDA Orphan Drug Designation.
Benefits of FDA Fast Track designation are:
-Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
-More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
-More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
-Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
In addition to FDA Fast Track, might also try the other 3 FDA designations to speed up the approval process such as FDA Breakthrough, FDA Accelerated Approval, and FDA Priority Review.
Brazil is corrupt socialist country and PLX is run by greddy morons who use PLX stock as personnel ATM.
madeofcandy • Remember when I told you to sell PLX at $7 at $6 at $4 at $2 now I bet you wish you listened to me. Wishing a stock up will not make it happen but record earnings and Profit $$$$ will.
Here is a new Tip::: Pleas vote for all GOP ticket come Nov. 2016 or the USA will go down the toilet like PLX stock price did the past 2 years. Always listen to your Doctor not corrupt lying folks in government or PLX overpaid top management. Sell PLX a dead dog stock.
Brazil Ministry of Health and Fiocruz broke the supply agreement badly. Protalix does not mention any financial penalties for Fiocruz. How come Protalix does not sue? The supply agreement is for $40 million. Brazil is on pace to do about $3-4 million this year. So Fiocruz is ordering less than 10% of the amount specified in the supply agreement.
In Brazil, Cerezyme must still have about 80% to 90% market share. Why is Brazil and Fiocruz not switching patients over to Protalix's Uplyso? I would estimate there are around 25 patients on Uplyso if price is around $150,000 annually. Brazil has around 600 Gaucher patients.
I posted a couple of times about PRX-102 not having Orphan Drug Designation way back in November 2015. I have also tried contacting Protalix back in October 2015 about this. It is seven months and still no Orphan Drug Designation either at FDA or EMA (Europe) databases.
I do not know why Protalix is so slow. I would say Protalix made a bad mistake. Most companies apply for Orphan Drug Designation as early as Phase 1. Protalix is entering Phase 3 with PRX-102.
Protalix passed up United States Orphan Drug Tax Credits for 50% of the Phase 2 expenses held in the United States. Phase 2 has lasted around 3 years. The tax credits start when Orphan Drug Designation is granted and is not retroactive. That means Phase 2 expenses do not get any Orphan Drug Tax Credits.
Also, EMA (Europe) gives Orphan Drugs reduced fees for protocol assistance. The latest 10-Q says Protalix has been communicating with the EMA about designing phase 3. So Protalix probably did not get reduced fees from the EMA.
Get out now____________before it goes to ZERO000000000000000000
If Trump was running PLX the company would be making a nice profit and the stock would not be listed on Pink Sheets with all the #$%$.......Sell before they go Ch-11 and your lose your 82 cents.
Sentiment: Strong Sell
PLX = loser stock just like Obama is a loser, lying US President and Hillary if elected will be the same. Sell all 3 losers.
Sell PLX before company goes bankrupt. Get Out now.
I told all you folks PLX stock was used as a ATM by the incompetent top management. I bet you wish you listened to me now. Vote the all out on next proxy and vote democrats all out in Nov. 2016 elections......win-win again.
PLX was worst stock the past 8 years like Obama has been worst President in US History.
Stunned by Trump?s dominance, Hillary now taking 20 Mg. of Prozac daily for depression. Sorry Liberals but Hillary will need more than Prozac when she has to debate Trump. Buy Lilly or Pfizer not #$%$ like PLX run by greedy jewish morons.
FOLKS SELL PLX and Most Democrats are embarrassed by the lies, incompetence and utter failure of Obama & Hillary Clinton. Many will vote for Trump in Nov. I plan to vote for Trump or Cruz as a Reagan democrat.
Get out of the garbage. Stocks below $8 Bucks are #$%$.
Buy #$%$ stock like PLX run by greedy incompetent morons these is what happens and when you elect #$%$ like Obama look what he does to the USA and World.......makes a mess for the next President to cleanup.
Short ratio is circa 22. Ie, 22 days are neded to cover. If good news pop in the shorts will be burned.