then filing for ED and eventually ED approval.... what else? Will a migraine partnership move the sp much?
They havent started the final study yet... once they do, it will take a couple of months... I am expecting them to file the NDA in the spring and FDA decision coming sometime around April of 2015.
Can you put a valuation on these apps? I have 10$ for migraine and ED,,, the rest of the pipeline? 50c of the sp today is for the app they have on the market now...
I thought it would take one month for the FDA to announce which class it will be.... I expect the FDA to announce in early April the class... and thus, since I am expecting a class 1, approval will come in early June... Then the launch... then EMA... and ED news.
Valuation - I have 40-50c eps for migraine alone and ED is worth 30-40c... Thats 10$ + the pipeline...
What other apps do the techs have?
Sorry but approval for ED is one year away... the final trial and then submission... then approval... 1 year away at best.
I think word is getting out that Foc sales are doing well... plus each day that goes by is a day closer to the next approvals... I think we will see over 30 milUSD in sales of Foc for six months.
I suspect now partnership will be announced for a while and likely after the final trial. I do think we will see news from the FDA for a class review soon. But that's it.
That happened much faster than expected... so how long will it take for the FDA to decide on a class A or B response? Next PR should be a partnership or the beginning of the final trial for ED...
I think the company could do a better job of getting the word out there... no news on the company. The web site should be updated as well.... when will HT be filed? When is opioid expected? Near term events such as MAA and partnerships could be discussed.
As the SA article stated, the CRL is about as positive as could be... packaging and labeling are not major issues and can be dealt with... 3rd party manufacturing is often raised... when they announce the review date it will either be 2 or 6 months and I am confident that RDHL and IGXT will have it worked out. But in biotech, anything is possible.