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3 years ago

Before a significant risk medical mobile app (MMA) study can commence, what does the sponsor need to do

1 answer:

3 0

Based on operational standards, before a significant risk medical mobile app (MMA) study can commence, the sponsor "<u>must have an approved IDE from FDA."</u>

IDE is the acronym of Investigational Device Exemption. Approval of IDE validates the investigational device to be utilized in medical research to obtain safety and efficacy data.

Similarly, FDA is the acronym of Food and Drug Administration. The responsibility of the FDA is to ensure there is safety and security of human and veterinary commodities, including drugs, biological products, and medical devices, among others.

Hence, in this case, it is concluded that the correct answer is that the sponsor "<u>must have an approved IDE from FDA."</u>

Learn more about the FDA here: brainly.com/question/14164603

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Castle, Inc., has no debt outstanding and a total market value of $150,000. Earnings before interest and taxes, EBIT, are projec

Klio2033 [76]

Answer:

c-1. ROE under Recession = 8.34%; ROE under Normal = 10.82%; and ROE under Expansion = 12.71%.

c-2. % change in ROE under Recession = -22.91%; and % change in ROE under Expansion = 17.46%.

c-3. ROE under Recession = 10.82%; ROE under Normal = 14.67%; and ROE under Expansion = 17.51%.

c-4. % change in ROE under Recession = -26.23%; and % change in ROE under Expansion = 19.41%

Explanation:

c-1. Calculate return on equity (ROE) under each of the three economic scenarios before any debt is issued. (Do not round intermediate calculations. Enter your answers as a percent rounded to 2 decimal places, e.g., 32.16.)

Note: See part 1 of the attached excel file for the calculations of Net Income, Shareholders' Equity, and return on equity (ROE) under each of the three economic scenarios before any debt is issued.

In the attached excel file, return on equity (ROE) is calculated using the following formula:

ROE = (Net income / Shareholders' Equity) * 100

After applying the ROE formula, the following are then obtained:

ROE under Recession = 8.34%

ROE under Normal = 10.82%

ROE under Expansion = 12.71%

c-2. Calculate the percentage changes in ROE when the economy expands or enters a recession. (A negative answer should be indicated by a minus sign. Do not round intermediate calculations. Enter your answers as a percent rounded to the nearest whole number, e.g., 32.)

Note: See part 1 of the attached excel file for the calculations of the percentage changes in ROE when the economy expands or enters a recession.

In the attached excel file, percentage changes in ROE is calculated as follows:

Percentage change in ROE = (ROE under recession/expansion - ROE under Normal) / ROE under Normal

After applying the Percentage change in ROE formula, the following are then obtained:

% change in ROE under Recession = -22.91%

% change in ROE under Expansion = 17.46%

c-3. Calculate the return on equity (ROE) under each of the three economic scenarios assuming the firm goes through with the recapitalization. (Do not round intermediate calculations. Enter your answers as a percent rounded to 2 decimal places, e.g., 32.16.)

Note: See part 2 of the attached excel file for the calculations of Net Income, Shareholders' Equity, and return on equity (ROE) under each of the three economic scenarios assuming the firm goes through with the recapitalization.

In the attached excel file, return on equity (ROE) is calculated using the following formula:

ROE = (Net income / Shareholders' Equity) * 100

After applying the ROE formula, the following are then obtained:

ROE under Recession = 10.82%

ROE under Normal = 14.67%

ROE under Expansion = 17.51%

c-4. Given the recapitalization, calculate the percentage changes in ROE when the economy expands or enters a recession.(A negative answer should be indicated by a minus sign. Do not round intermediate calculations. Enter your answers as a percent rounded to 2 decimal places, e.g., 32.16.)

Note: See part 2 of the attached excel file for the calculations of the percentage changes in ROE when the economy expands or enters a recession.

In the attached excel file, percentage changes in ROE is calculated as follows:

Percentage change in ROE = (ROE under recession/expansion - ROE under Normal) / ROE under Normal

After applying the Percentage change in ROE formula, the following are then obtained:

% change in ROE under Recession = -26.23%

% change in ROE under Expansion = 19.41%

Download xlsx

3 0

3 years ago

Anya recently graduated and has just started a job at a large company. She had to take out many student loans to cover the cost

stepan [7]

Anya uses her smartness and cost effective technique to save money as she is making proper strategy before deciding to invest in anything.

The technique to save money here and replace and return clothes is the example of cost effective technique that defines how effectively and efficiently one can utilize their resources and save the investment of money.

A strategy is something that would be required to make the plan work and take it into the action so that the best outcome is achieved by anyone applying it.

To learn more about cost effective technique here,

brainly.com/question/14287321

#SPJ1

6 0

1 year ago

Farris Corporation, which has only one product, has provided the following data concerning its most recent month of operations:S

RoseWind [281]

Answer:

c. $17,400

Explanation:

The computation of the net operating income under absorption costing is given below:

unit product cost under Absorption costing

direct materials $29

direct labor $71

variable manufacturing overhead $17

fixed manufacturing overhead ($142,500 ÷ 9,500) $15

unit product cost $132

Now

Sales (9,100 × 156) $1,419,600

less:Variable cost of good sold (9,100 × 132) $1,201,200

Gross profit $218,400

Selling and administrative expense

variable selling expens (9,100 × 21) $191,100

Fixed selling & adm expense $9,900

Net operating income $17,400

8 0

3 years ago

Trespass to land is committed if, without the permission of the property owner, a person

Gennadij [26K]

We are to explain what trespass to land meant.

Trespass to land is committed if, without the permission of the property owner, a person <em>"causes water to back up onto the property"</em>

Trespass to land is a punishable offence under the law. An individual must not go beyond the boundary or limit of his own property. There shouldn't be any form of interference in the property of someone else.

For instance, a person goes to another person's compound to plant vegetable has trespassed except if he or she is given the permission to do so.

Therefore,

Trespass to land is committed if, without the permission of the property owner, a person <em>"causes water to back up onto the property"</em>

brainly.com/question/11711008

6 0

3 years ago

1. The government is mulling protecting the shoe industry. It estimates it needs to protect it for 6 years to the tune of $5 bil

faust18 [17]

Answer:

PV of cash outflows = Annuity*(1-1/(1+rate)^number of terms)/rate

= 5000000000*(1-1/(1+9%)^6)/9%

= 22429592951.15

PV of inflows at end of 6 years= Annuity*(1-1/(1+rate)^number of terms)/rate

= 200000000*(1-1/(1+9%)^100)/9%

= 2221820304.00

PV of inflows now = 2221820304/1.09^6 = $1,324,798,853.47

NPV = -22429592951.15+1324798853.47

= -21104794098

We see that the Net Present value added by this method is negative. Hence the project is not beneficial.

5 0

3 years ago