Drugs don't get approval that fast. Even with a rolling NDA. First we have to see PR on the NDA being actually filed. They haven't done that yet.
Once filed, acceptance by FDA to setting a date for approval could be as long as 6-10 months of time depend on FDA schedule and treatment of this drug approval process. If they file in Q4, we should expect an approval date in second half of 2018. That's the realistic time frame to approval.
After filing the NDA and FDA sets a date for decision, you still have independent FDA committee review to see whether or not the committee would recommend approval. Getting favorable recommendation from the committe would almost guaranty approval.
Realistic time frame is second half of 2018. That's when milestone payment would come in. Don't be surprised if you ended up holding this for far longer than you think. Unfortunately, there aren't any near catalyst that would really make this run but there might be better entry point coming up.
Even if they get yet another extension from NASDAQ they only have 180 days or about 6 months of time, and I doubt that would be enough until Aldox approval unless management do something else to try and bring the share price up above 1$.
They need more funding for sure, perhaps an offering of above 1$ could help but I am not sure management could convince investor or lenders to buy at 1.10 like NantCell did.
I bet NantCell deal was SK's plan to bring this over 1$ but it didn't work like he expected. The mistrust and confidence of K and team is way lower than he estimated. He might be saying to himself, Oops, I messed up big now, how do I fix this?
I do believe listing issue is of top priority. Because, if this goes to OTC, they would absolutely lose confidence and it be even harder to build any confidence into this company.
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