@George1972
Hey George thanks for your feedback and support,
George although I do understand your sentiment with regards to SAE,s unfortunately I cannot repay you, with the same compliment, as I don't agree with what you say
We cannot move forwards on WHAT IFS
We are in the Biotech space I have been here for years now, as I know others have along with yourself,
This is the risk we carry and have carried along the way, what if this, what if that.
What you talk about being unable to move on is exactly the same situation we have been in for the last ten years
Note
16 September 2014 ATL1102 for MS further development plans
– US FDA Pre-IND response timing confirmed; European Patent Allowance Antisense Therapeutics Limited (“ANP” or “the Company”
is pleased to advise that it has received the US Food and Drug Administration’s (FDA) response to the Company’s formal request for a Pre-Investigational New Drug (Pre-IND) assessment of ANP’s plans for further clinical development of ATL1102 to treat multiple sclerosis (MS).
The Company is also seeking FDA guidance and agreement on the intended content of the planned IND submission, including the proposed Phase IIb clinical study design and supporting non-clinical toxicology studies. The FDA has confirmed that its goal date for providing written responses to the Company’s previously submitted questions is October 17, 2014.
Antisense Therapeutics’ CEO and Managing Director Mark Diamond said: “The receipt of the FDA guidance will be a pivotal step in the continued development of ATL1102. A positive outcome would underpin our partnering and commercialisation plans for this drug and allow us to capitalise on the substantial development and investment made to date in this project asset.”
Please note the date above 2014
Atl1102 sat for nearly 7 yrs with permission to move forwards with an IND when we eventually did we were faced with a road block clinical hold through the FDA which eventually got revised to 25mg max dose and has been since then
FDA route Stranded at the moment, or use funds to carry out the tox study
We have Atl1103 parked at the moment successful Ph2 Trial Complete
We have what appears to be advances in the Leukaemia field in regards to Atl 1102 and its modulation of disease into the blood stream and ability to kill disease left in the bone marrow
We have Atl1101 Parked again through lack of funding
So without moving into any further indications I think its quite clear that we have more than enough to be going on with for the time being all successful to this point in time i may add
I understand your concerns George,I do, but as gassy said he actually beat me to it our MS trial was dosed at
600Mg Gassy for the first two weeks then reduced to
400Mg for the remainder of the trial
MS is a serious life threatening disease that eventually comes to a sad end and we have a drug that could help these people, especially in the SPMS the advanced stages of Ms yet it is parked
I have been through all the what ifs and set backs you could ever think of in this company but do you know what George never once has this
pipe line ever let me down, and that is the single most important reason I am still around here,
I have faith in the pipeline, and that's as far as it goes
George why should we now of all times be willing to Accept Mediocre if these Pharma
do not want to cough up, then Screw them, not us, don't accept mediocre
There is more than one way to do a deal and de-risk the route I mentioned prior, although I would hang tough on my original so long as the outcome didn't change I would be fine with some thing along the lines of this
$200mil upfront on partnering
+ $80mil in scrip on partnering @ 30c 266,666,666 new shares issued
+ $720mil payment
only on successful completion of trial with favourable results
+ $350mil payment on marketing approval
+ royalties ongoing
Pharma has choice to accept EMA Global rights or wait for an FDA decision either way on marketing approval for the EMA all moneys to be paid in full
PHARMAS UP FRONT RISK $200mil GUARANTEED TO MARKET
Which is a damn site better deal than they ever gave ROCHE
Then set this up from the partnering to list on the Nasdaq and grow and take our place on the big screen
Step two the CR route going it alone
I have no problem with a CR if they actually go for it as in
Lets Say approx $38mil for approx 140,000,000 @ 27c example only
Gives us the funds to move into the trial
But on declaring this CR inform the market that we will be heading to the Nasdaq with an ipo looking for a further $80mil to advance our pipeline in the US
Dont hide in dark corners with this, let these Pharma and our investors know we are going for the jugular we are going to do this with or without them,
I valued this long term I KNOW WHO AM I, OK IN MY UNPROFFESIONAL OPINION with a billion SOI @$19.00 giving a MC of $19bil and I believe if the ducks line up and we are marketed accordingly then even this figure is conservative when you look at the possibilities
Get these next two issues out of the way in the go it alone scenario, and trial success I doubt we would have to tap the market again to get there
Sorry George not having a go mate I do respect your views just mine are different,
where I do totally agree with you is that this next financing/Partnering move will define my future investment with ANP
I am sick of conservatism and mediocre
WE HAVE THE GOODS
WE HAVE THE SCIENCE
NOW IS THE TIME
I want TRUE VALE
See how we go
(20min delay)
