Else Nutrition Holdings Inc T.BABY

infant

[doggy123]

Could someone specify when the infant formula pending will be approved by the FDA.............when it happen the stock will explode for sure...........in the news the other day they said infant milk 80% is going to China and companies can't keep up the demand with explosive price........man can't wait for this approval

[ForesstGump]

Saw in a youtubde video where the ceo said it could take total of 2 years with all the back and forth. That would definately be a game changer

[doggy123]

How long ago roughly you seen this video ForesstGump...thanks in advance 

[m8magic]

link...??

[majortom75]

Not much additional info in their MD&A from last month but I also read somewhere recently that once they complete their clinical trial. it would be 18 to 24 months to approval. They've had difficulty sourcing a competing formula to act as a control in their study due to formula shortages in the US.

[majortom75]

Found it! "FDA approval pending on infant formula for U.S. expansion anticipated within 18 - 24 months from start day of the clinical study – currently in discussions with FDA on the study protocol and preclinical studies alignment" From their latest investor slide deck on their website. https://assets-global.website-files.com/63a1733b57a05c5d8230011c/64f9e2146523a6b54fab0d84_Else

[m8magic]

Does FDA approve infant formulas before they can be marketed? No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.

[m8magic]

o substantiate a new formulation, a manufacturer of an infant formula must conduct a growth monitoring study (GMS).  21 CFR Part 106.121 details the components of a GMS. ‍How long is the study? The study is 16 weeks long and infants must be no more than 11 days old at the time of enrollment. What information do we collect? Formula intake Anthropometric measurements

[m8magic]

so clinical study time is only 16 weeks...and the requiement is only min of nutritional ingredients...FDA approval is NOT REQUIRED