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Whether youre managing: Celiac Disease & Gluten Sensitivity: Peptides help fortify the intestinal barrier, mitigating the impact of accidental gluten exposure

Cannistraro, R

Fixed leasing agreement Pages Sold Revenue (1) (2) 30,000 45,000 60,000 75,000 90,000 30,000 $.20 = $ 6,000 45,000 $.20 = $ 9,000 60,000 $.20 = $ 12,000 75,000 $.20 = $ 15,000 90,000 $.20 = $ 18,000 Variable Costs (3) 30,000 $.15 = $4,500 45,000 $.15=$6,750 $1,500 Operati ng Income (Loss) (5) = (2) (3) (4) $ 0 $1,500 $ 750 0.20 150 60,000 $.15=$9,000 $1,500 $1,500 0.20 300 75,000 $.15=$11,25 0 90,000 $.15=$13,50 0 $1,500 $2,250 0.20 450 $1,500 $3,000 0.20 600 3-47 Fixed Costs (4) Prob abi lity (6) Expected Operating Income (7)=(5) (6 ) 0.20 $ 0 EA Expected value of fixed leasing agreement $1,500 Commission-based leasing agreement: Pages Variable Sold Revenue Costs (1) (2) (3) 30,000 30,000$.20 = $ 6,000 30,000 $.17 = $5100 45,000 45,000$.20=$ 9,000 45,000 $.17=$,7,650 60,000 60,000$.20 = $ 12,000 60,000 $.17 = $10,200 75,000 75,000$.20=$ 15,000 75,000 $.17=$12,750 90,000 90,000$.20=$ 18,000 90,000 $.17=$15,300 Expected value of commission based agreement Operating Income (4) = (2) (3) $900 $1,350 $1,800 $2,250 $2,700.00 Probabil ity (5) 0.20 0.20 0.20 0.20 0.20 Expected Operati ng Income (6)=(4)(5) $ 180 270 360 450 540 $1,800 Sunshine should choose the commission-based agreement because the expected value is higher than under the fixed cost leasing agreement

That said, our interactions with prescribing clinics have revealed certain specifics to us

FDA identified possible immunogenicity risks from aggregation and peptide-related impurities and proposed not adding either defined TB-500 substance to the 503A Bulks List