Interesting! I believe you have a logical argument in this article. What are your thoughts on any risks involved in completing the final phase of the trials, specifically the data from 100 patients over a year? Do you foresee any risks?
Not really, I think even if it shows some safety hazards at 1 year you already have the good results at 6 months so it would just be a label warning to cap the amount of times you can order it essentially.
Thanks for the update. I have a few follow on questions:
Do you have any thoughts on why the stock has sold off on this news?
It seems they will need to raise additional cash with their cash runway going through Q3 and the earliest potential NDA approval happening in October. Do you think they would sell before a decision from the FDA? It seem more likely they would sell afterward assuming NDA approval. Or maybe they could structure an option deal with a potential buyer to get them over the hump, like ALDX did with AbbVie. Has management discussed their plans on this point?
Dilution by Q3 probably won't be too bad because the stock will almost be completely de-risked at that point. If there are no issues in the last study then they will get a pretty good valuation for their next raise. Depending on how much it runs up you could see a sale before, but the market will definitely start pricing it in before. Management has made it clear that they want minimum dilution going forward and to sell the company.
This might be a dumb question but since Cytisinicline has been used in Europe for decades, what's to stop competitors from seeking FDA approval for a reformulated or generic version? Would their patents protect from that happening? Just trying to wrap my head around the defensibility of their version of Cytisinicline when its been in use in other countries.
Their patent is on the delivery/binding process and I think it’s fairly robust. Cytisine (the plant from which this is derived) is actually not as effective/impactful as Chantix. With the patented tech that makes it more effective they are able to get better results.
Interesting! I believe you have a logical argument in this article. What are your thoughts on any risks involved in completing the final phase of the trials, specifically the data from 100 patients over a year? Do you foresee any risks?
Not really, I think even if it shows some safety hazards at 1 year you already have the good results at 6 months so it would just be a label warning to cap the amount of times you can order it essentially.
Thanks for the update. I have a few follow on questions:
Do you have any thoughts on why the stock has sold off on this news?
It seems they will need to raise additional cash with their cash runway going through Q3 and the earliest potential NDA approval happening in October. Do you think they would sell before a decision from the FDA? It seem more likely they would sell afterward assuming NDA approval. Or maybe they could structure an option deal with a potential buyer to get them over the hump, like ALDX did with AbbVie. Has management discussed their plans on this point?
I have absolutely no idea why it's sold off.
Dilution by Q3 probably won't be too bad because the stock will almost be completely de-risked at that point. If there are no issues in the last study then they will get a pretty good valuation for their next raise. Depending on how much it runs up you could see a sale before, but the market will definitely start pricing it in before. Management has made it clear that they want minimum dilution going forward and to sell the company.
This might be a dumb question but since Cytisinicline has been used in Europe for decades, what's to stop competitors from seeking FDA approval for a reformulated or generic version? Would their patents protect from that happening? Just trying to wrap my head around the defensibility of their version of Cytisinicline when its been in use in other countries.
Their patent is on the delivery/binding process and I think it’s fairly robust. Cytisine (the plant from which this is derived) is actually not as effective/impactful as Chantix. With the patented tech that makes it more effective they are able to get better results.