Unfortunately I believe delays in approval in the US for Vivagel have further impact than just the US.
How many other regions would have relied upon FDA approval for Mundipharma territories?
I believe a lot of shareholders already had an over optimistic timeframe for Mundipharma to launch in major territories around their area of responsibility.
I have some thoughts regarding timeframes that people can decide for themselves.
1. The approval process for drugs in latin America is lengthy and it may take upwards of approximately 1.5 years.
2. Europe is going through Brexit. The impact of Brexit is a concern and quite frankly I do not know the possible added hurdles however I expect delays in the approval process at the least.
Lets hope our lead candidate does not give us the same fate of what the Nanotechnology platform Accurins did when it failed to show efficacy when trying to improve Docetaxel. I'm 3/4 sold out of Starpharma, I still foresee dropping to a value closer to 80cents when clarification hits about the need for further trials for Vivagel. The potential from Vivagel for quite some time will be minimal in my opinion and any further setbacks could be devastating. At this point I feel that Astrazenica just maintain ties with Starpharma so they can sweep in and buy Starpharma for peanuts if it misses with DEP Doxetaxel just as another company purchased the company that owned Accurins for cheap when it failed to improve Doxetaxel.
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