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Emmac Life Sciences has it's fourth Director
Thomas George Ellen.
That is all.
FFWD won’t move until we get the RNS..Will be impossible to buy when it lands and will rerate to a value that will cause many an eye to water.
That RNS moves ever closer.
Agree with every word Quint
Yes, the figures, if Intensity is bought out, are potentially staggering, even though FFWD owns less than 2% of the company. In rough numbers, every £1bn valuation adds about 12p to the NAV.
https://www.gfmag.com/mag azine/febr uary-2019/race-new-cancer-drugs-sparks-wave-takeovers
https://www.iris htimes.com/bus iness/health-pharma/eli-lilly-to-buy-cancer-pharma-company-for-8bn-1.3750078
Don't know if these links will work on here (will need to close the gaps), but they do give a flavour of what's going on in the Oncology space
Intensity will do a JV with a major or outright sale... all there in the series B document from series A lead investor.
What's the fuss with #FFWD today?
Well one of its Investee companies has been Fast tracked by the FDA because it meets the criteria below.
Companies at similar stages have been bought out for billions before the end of their trials.
The company is called Intensity Therapeutics:
The eligible drug must show some advantage over available treatment, such as:
*Showing superior effectiveness
*Avoiding serious side effects of an available treatment
*Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
*Decreasing a clinically significant toxicity of an available treatment
*Addressing an expected public health need.
Very nice RNS but it's not quite accurate to say it's a 'big step towards commercialisation' robrob.
Phase 2 trials typically average 2 years; Phase 3 trials maybe longer. If they are successful then they submit NDA, say at least another year. So, quite some way off being commercial.
What the 'fast track' designation does do is help Intensity promote themselves and it may increase interest from potential suitors with very deep pockets. Here's hoping anyway
yes maybe we should of moved at the open, but for me we are being held back for a reason, what that reason is I really don't know, so how long were in this range depends on the reason, GLA
yeh ur right,not woken up yet lol
It's been NT for a about 20 mins on and off with only £150 buy allowed.
Other than that I've no idea what's going on.
You are able to sell way about 100k shares though.
Poor market, not a sexy penny stock, flat IR/PR, news slow to arrive, difficult to assess the worth of news like today's - take your pick, but sooner or later a catalyst WILL arrive to make this take off, and the event won't necessarily be signalled. That's old Snooty's view.
dont understand, thats a fantastic rns so why no more buys/?????
Deramp That RNS....
I dare you.
That's a very positive RNS!
Looks like a big step towards commercialisation has occurred.
Whoops, should have looked before I leaped!
Yesterday's Insilico news was a prime opportunity to publicise it and our great portfolio to the wider world. There is still time today, I suppose - I wonder if we'll get an RNS?
No One Cares
Put FFWD in a little shoebox and kick it to the back of your wardrobe.
well.
Imagine knowing about a fast track of FDA investment before an official RNS...
Nice heads up pre RNS
BOOOOOM!
Fast track (FDA) Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.
WESTPORT, Conn., April 17, 2019 (GLOBE NEWSWIRE) -- Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of its proprietary therapeutic agents, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s development program evaluating INT230-6 for the treatment of patients with relapsed or metastatic triple negative breast cancer (TNBC) who have failed at least two prior lines of therapy.
“We are extremely pleased to receive this Fast Track designation, which validates the potential of INT230-6 to treat patients with relapsed or metastatic triple negative breast cancer as a single agent,” said Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. “Finding improved therapies for this disease is a critical unmet medical need, and we look forward to working closely with the FDA this year to initiate a Phase 2 clinical study for this indication.”
Approximately 15-20% of breast cancers test negative for estrogen receptors, progesterone receptors, and excess HER2 protein, qualifying them as triple negative. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer, mainly because there are fewer targeted medicines. According to a study published in the Journal of Clinical Oncology, patients who fail two lines of therapy for TNBC typically progress within nine weeks. Those who have failed three lines progress within four weeks.
“This important regulatory designation is based on the promising data observed to date from use of INT230-6 in our breast cancer research,” said Ian B. Walters, M.D., Chief Medical Officer of Intensity Therapeutics. “The Fast Track designation will allow us to engage robustly with the Agency to most effectively and efficiently develop our new cancer treatment approach, as well as help us determine other potential indications to pursue for INT230-6. To date, our ongoing Phase 1/2 trial has treated patients with more than 14 different types of advanced solid tumors including TNBC, and we look forward to evaluating use of INT230-6 in other areas for potential registration-enabling studies.”
The FDA’s Fast Track program facilitates development and expedites the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A fast track drug must show some advantage over available therapy. Fast Track designation allows early and frequent communication between the FDA and a drug company, often leading to earlier drug approval and access by patients. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.