The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
No its not accurate to say "FDA Appoval" because that is specifically reserved for marketing authorisation for a drug. Yes, we are awaiting a communication from the FDA which is currently blocking us from entering clinical trials.
There seems to be quite a lot of confusion/misuse of terms here about the expected upcoming FDA communication. "FDA Approval" means the drug can be marketed (sold) as data has been reviewed from (normally) 3 trial phases (PI, PII and PIII). Hemogenyx is still pre-clinical with all its candidates - i.e. hasn't even entered PI clinical trials, let alone been "FDA Approved"! The current situation is that we are hoping for consent from the FDA to commence Phase I clinical trials of HEMO-CAR-T. Not a "de-ramp" at all, just to say that it is one thing to enter PI and quite another to have FDA Approval!!
The only thing that matters in a patent is the Claims (the last 2 pages), as this is what is actually protected. You can put whatever you want in the description, hence the long lists of diseases/targets/species that are the norm in biotech patents. The patent protects the actual antibody set out in the sequence listing (a "composition of matter" patent), not a method/process of using the antibody to treat a condition etc. Normally companies would file several patents to protect the molecule and the use of the molecule to treat disease X etc.
now
it will come back up and finish around, or just below, level
9.575 to sell, what a joke
AIM never ceases to amaze me
..
very nice! thanks for the info
lol, well at least we both picked up on the same things! any predictions for the day? as trebor said yesterday, we have had good momentum up until today so lets hope we can profit from todays confirmation of excellent growth and an extremely positive start to 2013.
Highlights: § Group revenue increased by 73% to £7.94m, (2011: £4.59m) § Revenue from Dual-Fuel™ division increased by 101% to £6.64m, (2011: £3.30m § Gross profit increased to £3.52m (2011: £2.56m), driven by Dual-Fuel™ systems and development revenue § £3.20m of cash at 31 December 2012, (2011: £2.42m) § £3.35m (before expenses) successfully raised through equity issue in September 2012 "Our momentum has continued into the start of 2013 with customers having already placed more than 150 new orders either with Clean Air Power or our European OEM partner for Dual-Fuel™ systems. Factory production by our European OEM partner has also increased and we have delivered 20 of our Genesis-EDGE branded systems to a customer in Spain." I am very happy with the results, it would be crazy not to see a nice rise on the back of this. Any thoughts? GLA
tomorrow guys. I will be up bright and early digesting the RNS if it comes at 7am.
looks like the last trade today was at 12:36!! Not what I was expecting the day before results!
i'm waiting until tomorrow at the earliest to sell, hope i'm making the right decision! GLA
is this drop people derisking before results? or manipulation/low volume?
nice article, thanks
If only we could get a repeat of Jan 2012 when the sp went from 7 to 17p. With the golden cross coupled with news of the strong order sheet that we are expecting....... who knows! GLA
I get easily excited by blue days, have had a bit of bad luck recently with some absolute dogs. Lets hope this is the turning point! lol. I am hoping for 14p+ in the near future, with a positive statement on Thurs. GLA