LTP ltr pharma limited

Ann: Investor Presentation, page-27

  1. 17 Posts.
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    The difference between the companies you mentioned above and LTP is huge actually. LTP took an existing drug that was approved by the FDA and regulatory agencies around the world for more than a decade, and only changed the formulation slightly for a new delivery method. The drug is also already prescribed in the Australian market under TGA special access scheme which indicates that this is a serious company with a legitimate product that is market ready."Those familiar with with biotech/pharma industry" understand that when you take an existing approved drug you do not need 100s of millions nor many years to get approved. There is something called 505 (b) (2) FDA application that helps companies like LTP in cutting costs and timeframes in the approval process. As mentioned in their many presentations LTP will be filing under that process and if all goes smoothly they will be approved and market ready in 2025.As for the approval in Australia through the TGA, since the product is already on the market via the special access scheme the expedited approval process which LTP will file under can take up to 90 days for approval.One last point, The company is now well funded to take through the entire approval process and early commercialization as mentioned in the presentation. As mentioned in the presentation they are funded until the end of 2026.
 
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Change
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