Posted On: 03/24/2015 10:52:38 PM
Post# of 30070
ESS Moving Forward. Of course it's speculating. But to what degree is it speculation if renowned MD's verify that these drugs work.
Below are some reasons why ESS will be approved and be very receptive in the market. I have and will continue to put money on it.
Despite the checkered past, those are some strong endorsements by key opinion leaders in the burn space. Below we summarize some of the positive attributes that Amarantus has going for it with respect to moving ESS forward:
- Strong KOL support (note the comments from Drs. Ahernholz and Gibron),
- Potential for strong pricing power (note the cost to care for severe-burn patient and ODD status),
- New active IND (releasing the previous clinical hold from 2007),
- Approved protocol for a Phase 2a study (already listed on ClinicalTrials.gov),
- Active AFIRM grant for $1.3 million, with potential to expand based on previous $18 million award (pulled when the FDA placed the product on clinical hold),
- Relatively quick path to market (thanks to ODD) and potential for priority review / expedited approval,
- Meaningful potential for label expansion beyond initial Orphan population (if ESS works, we believe treating physicians will clearly want to use the product in patients with TBSA < 50% as well), - Large market opportunity, estimated at $500M per year (based on pricing x number of patients).
Below are some reasons why ESS will be approved and be very receptive in the market. I have and will continue to put money on it.
Despite the checkered past, those are some strong endorsements by key opinion leaders in the burn space. Below we summarize some of the positive attributes that Amarantus has going for it with respect to moving ESS forward:
- Strong KOL support (note the comments from Drs. Ahernholz and Gibron),
- Potential for strong pricing power (note the cost to care for severe-burn patient and ODD status),
- New active IND (releasing the previous clinical hold from 2007),
- Approved protocol for a Phase 2a study (already listed on ClinicalTrials.gov),
- Active AFIRM grant for $1.3 million, with potential to expand based on previous $18 million award (pulled when the FDA placed the product on clinical hold),
- Relatively quick path to market (thanks to ODD) and potential for priority review / expedited approval,
- Meaningful potential for label expansion beyond initial Orphan population (if ESS works, we believe treating physicians will clearly want to use the product in patients with TBSA < 50% as well), - Large market opportunity, estimated at $500M per year (based on pricing x number of patients).
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