It took approximately 5 weeks (20th March) to be granted a meeting with the FDA following the CRL, another 6/7 weeks (3rd May) to for the meeting to take place and 5 weeks (6th June) to get a response (minutes) from that meeting so if the FDA /MTFB are following a similar time scale we should be due an update within the next week or two.
The market potential of TPR100 isn't as big as MED but it would still provide FUM with annual royalties in the 10's of millions.
Global sales of over the counter topical, non steroidal anti-inflammatory drugs is over $2.9 billion and the sales in the US alone are over $1 billion. These figures are from 2015 and the annual year on year growth of 15% so global sales could reach over $5 billion in 2020. (assuming growth has continued the same)
I appreciate that the revenue for Gatwick will not be seen until after 2020 but it was still another large contract win that secures future business so it was positive. I may have jumped the gun a bit quickly and purchased a load in the 185 to 190 range fully expecting a bounce after what seems to be a very big overreaction to the trading update which in my opinion seemed to be very positive.
dactions - No worries. I think it's good news that more supporting information has been requested; JB said that it's normal for the regulators to request more information on 3 or 4 occasions. I remember Thornton & Ross filed UK regulatory submission several months later then the timescale that was stated by JB so given the delay and their experience I hope that the regulators don't require to much more info and approval can be granted in the very near future. TPR100 is a massive product in its own right that will be on the market at least a year ahead of MED2005. I personally get rather frustrated that most on this BB only focus on MED2005 when TRP100 is completely de-risked and will be generating large revenues far more quickly.
I think many don't realise quite how large the transdermal pain relief market is.
Let's be honest, CSD500 was and still is a good product with high potential, the problem is that FUM got burnt in their agreement with ?Reckitt's and didn't learn from their mistake when entering into the licensing agreement with church and dwight. The time it took to get an extended shelf life was ridiculous and I think that a large reason for why the rights were returned.
The extended shelf life is now resolved and listening to JB and Ken it now appears that they have learned from their past mistakes. I hope that when TPR100 is approved and should the phase 3 trial of MED2005 be successful (no reason it shouldn't) that FUM will revisit the marketing of CSD500 or simply sell the asset.
Originally yes, news was due this month but T&R had feedback from the regulators, requesting more information which I believe they have submitted but it has pushed back approval a bit. see the video here:
LOL. The reason I bashed the idea of a Tesla is the build quality and customer service is terrible. My personal opinion electric cars need another couple of years to evolve, especially in terms of battery technology, and in the case of Tesla (and [possibly others) reliability.
Not to Mention that FUM have two blockbuster products the first of which TPR100 should pass approval later in the next 3 months and be in our pharmacies and supermarkets shortly after possibly generating hundreds of millions of pounds in sales.
That's what I thought. I thought COST was cheap after the fall last week and it was a good buy but I have watched the SP continue to fall this week for no apparent reason and noticed today the the majority of the trades were marked as "automated" so assumed that market manipulation was at work. Sad to see