How come no Orphan Drug Designation? I think it only takes FDA about 60 days to grant it. The FDA database has 9 drugs granted the designation, so it is like a no-brainer for FDA to give Orphan Designation to a Fabry drug. Protalix should have applied for the designation while drug was in phase 1. Drug is about to start phase 3. So I think the phase 2 expenses do not count for tax credits. Why is company so slow?
Protalix is probably passing up on United States Orphan Drug Tax Credits. A company can get tax credit for 50% of expenses used for clinical trials in the United States. The tax credits start when granted Orphan Drug Designation. I think Protalix has a 10 year tax-free status in Israel. So if Protalix is going to pay United States taxes some time in the future, maybe Protalix should take advantage of the United States tax credits.
Start date for P3 now given as H1 instead of Q1. Patients from earlier trials continuing in open label trial for up to full two years, with continuing presentations of data both this year and next. Schwab gives March 10 as earnings date.
The two P3s for Fabry--they've been waiting for the SPA--and proof of concept trials of drugs for cystic fibrosis and ulcerative colitis.
The registration P3 for Fabry is supposed to take about six months, and according to the 10-K the two proof of concept trials will each take eight weeks. Assuming success, PLX will then seek partners for further development.
PLX average = $393K
GROUP average = $493K
Averages Per Company In Group :
ADXS = $493K ---- AEZS = $432K --- ALXA = $581K --- AMDA = $119K
APRI = $234K --- ARNA = $462K --- ARQL = $621K --- ATOS = $623K
BIOD = $501K --- CERS = $521K --- CTIC = $882K --- CYCC = $423K
DSCO = $219K --- EXEL = $427K --- GERN = $662K --- GNVC = $420K
INO = $614K --- KBIOQ = $427K --- NSPH = $320K --- NSPR = $358K
NVAX = $546K --- ONTX = $484K --- OPK = $538K --- OREX = $692K
PSTI = $389K --- RDNT = $700K --- RXII = $454K --- SNSS = $602K
STEM = $636K --- TEAR = $433K --- UNIS = $525K --- VSCP = $294K
WGBS = $320K --- XNPT = $680K --- XOMA = $588K