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Stt not sure what point are you making here??? Asset looks decent, p2 data looks better than standard of existing care. Ongoing sales per patient over time as disease relapses rather than a one off treatment and done.
The POLB team confirmed the option comes with a small nominal cost but depending on DD what is needed for p3 spend will need some money to run trial but fda have agreed 80% patient aquisition in Turkey where trial costs are way lower than West such as UK and USA where prevalence is lower. Question on shore capital and what that may mean and JS referred to them being involved with amryt listing strategy and capital expansion. Make of that what you will. The guy from silk road ex fda regulatory so a job for him within polb might be very useful. A lot of small pharma struggle with dealings with fda, this guy knows both sides of orphan drug space. Fingers xd all.
Just in case you didn't see Sickothetech's very long post, I thought I'd share it again.
SpuddyMadrid,
That's history.
Look at the newsflow for PTX. There's newsflow in the public domain as to what has been happening with Silk Road Therapeutics, Soligenix's option agreement with Silk Road and phase 2a Behçet's Disease clinical study.
A year ago:
Soligenix Enters into Exclusive Option Agreement with Silk Road Therapeutics for Rights to Topical Pentoxifylline Designed to Treat Behçet's Disease
"The option agreement grants the Company the right to acquire a novel topical formulation of Pentoxifylline (PTX)"
https://www.prnewswire.com/news-releases/soligenix-enters-into-exclusive-option-agreement-with-silk-road-therapeutics-for-rights-to-topical-pentoxifylline-designed-to-treat-behcets-disease-301811424.html
Only a couple of months ago:
"Phase 2a clinical study of SGX945 in Behçet's Disease initiating in 2024"
"The initiation of a Phase 2a clinical study in Behçet's Disease later this year will be another important milestone for our company and we look forward to working with the MAB to advance this program."
Comprised of internationally renowned rheumatologists with extensive experience in Behçet's Disease, the MAB will play an important advisory role in the conduct of the upcoming Phase 2a clinical study, as well as in the design of subsequent clinical studies and associated regulatory interactions with health authorities. "
https://www.prnewswire.com/news-releases/soligenix-announces-formation-of-behcets-disease-medical-advisory-board-302057074.html
SpuddyMadrid,
That's history.
Look at the newsflow for PTX. There's newsflow in the public domain as to what has been happening with Silk Road Therapeutics, Soligenix's option agreement with Silk Road and phase 2a Behçet's Disease clinical study.
A year ago:
Soligenix Enters into Exclusive Option Agreement with Silk Road Therapeutics for Rights to Topical Pentoxifylline Designed to Treat Behçet's Disease
"The option agreement grants the Company the right to acquire a novel topical formulation of Pentoxifylline (PTX)"
https://www.prnewswire.com/news-releases/soligenix-enters-into-exclusive-option-agreement-with-silk-road-therapeutics-for-rights-to-topical-pentoxifylline-designed-to-treat-behcets-disease-301811424.html
Only a couple of months ago:
"Phase 2a clinical study of SGX945 in Behçet's Disease initiating in 2024"
"The initiation of a Phase 2a clinical study in Behçet's Disease later this year will be another important milestone for our company and we look forward to working with the MAB to advance this program."
Comprised of internationally renowned rheumatologists with extensive experience in Behçet's Disease, the MAB will play an important advisory role in the conduct of the upcoming Phase 2a clinical study, as well as in the design of subsequent clinical studies and associated regulatory interactions with health authorities. "
https://www.prnewswire.com/news-releases/soligenix-announces-formation-of-behcets-disease-medical-advisory-board-302057074.html
Interesting regarding Silk Road Therapeutics
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Clinical stage company focused on rare diseases and 505b2 regulatory pathway. Our lead product SRT-001 ($200M annual revenue potential determined by independent third party) for Behcet's Disease showed very promising results at the Phase 2 proof-of-concept trial. The results of the trial were presented at American College of Rheumatologyannual meeting on November 2019. On January 2020, our second product SRT-002 received a "May Proceed" letter from FDA for starting a Phase 2 proof-of-concept trial in the US.
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