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Just to keep the conspiracy theory alive :)

Maybe that's why Motif may Need to raise some cash! All we need to do now is raise some considerable cash, whereby the FDA nod the drug through, and then send tranches of dosh regularly to our appointed FDA reviewers.

https://www.independent.co.uk/news/world/americas/fda-drugs-companies-pharmaceutical-us-pay-doctors-approval-fompanies-astrazeneca-a8433621.html

Maybe the problem lies in the fact that the results are so good...the FDA want to see more data about this new age magic ...lets face it ...the results on paper look absolutely fantastic...even I can see that!..it does beg the question why can't the peeps in the industry ( im sure the phsrma industry is quite a small world really...and snything likely to cause a stir woukd be common knowledge) show any interest ...these results should make many a chemist who's working on a new age antibiotic cry with envy....but i just don't get the feeling in the industry press that it's happening...AIM is fUll of world changing products that we all need. ...and most fall by the roadside at some point....but this antibiotic has been proven to work...and the sp is on its knees....nd it is needed more than most other products..I'm Suprised the competition don't want it on their own books...if not for any other reason to protect their own market share....the company's only worth a fraction of what is sometimes paid for other products...

I dont normally believe in conspiracy theory's but the Pont made by some one regarding can anyone name a AIM company that won FDA approval and went on to take market share from the big guys ...is imo an intetesting thought...but just a thought with no evidence.

From what I've been reading the FDA have been highly critiqued in past few years for allowing drugs and other products onto market..only to have to withdraw drugs later because of evidence of toxicity. 1% death rate from say liver failure with a drug that only say 10,000 people use per year and the drug is a "last chance" drug = 100 liver toxic Death rate on terminally I'll patients... is massively different from say a heavily used antibiotic that say 500,000 peps use pa and is not a "last chance" option = 5000 dead patients from liver damage....does not sit very well imo.
Just random numbers selection to get my point over...FDA probably much more concerened with toxicology results from what could be a blockbuster than if it were to be used on terminally I'll, low patient numbers....especially if new drug promotes itself as liver friendly and will be used as drug of choice for this particular group of patients. .I. e patients with pre existing liver damage which I understand is 25% of current patients using our main competitors drug.

Waccy. Motif did not get such a notification regarding a delay but did recieve one, on allocated date specifically mentioning more data required re liver ....very specific. Do you know whether Motif in its FDA application specifically identified patients with liver complications as its primary target group...

What could be the worst question asked. The trial data given to FDA was successfull and Motifs offering has not Been rejected outright....the FDA can't replicate the trial....and even in a worst case scanario Motif are instructed to repeat the entire trial...very unlikely...then anyone investing after a succrssfull cash call ....should be in a good place longer term....we all know that most pharma stocks rise before FDA annoucements...and some investors only concentrate on these companys...same shoukd happen again...except next time with a fully conclusive result from FDA....it's all about cash to keep the compsny alive and time for Motiv now ....if we get the cash...then what a fantastic opportunity for new investors4. ..and the company are going to need new investors.
Apologies for spellings etc on mobile.

Im not an expert in pharms stocks.. but surely Even in a worst case scanario an investment here say 4 or 5 p after the next
Funding round .... would be a good investment in this company in the longer term...but with a very real possibility that the problem can be resolved in a much shorter term. Isn't this just one of those oppurtunitys that's buried beneath what looms like a catastrophe!
Much of the work has been completed.....I imagine there are many company's in early stage planning of new drugs that would love to be in this situation....the drug works...and has not been rejected on its efficacy ....plus we are assured effects on liver are only temporary.....

I'm sure it's been posted before but just in case ...here's it is.

http://www.freepatentsonline.com/y2018/0207291.html

What grabbed my attention was that the new product had no liver function issues and AbbVie only presented top line data form their phase 3 study to the FDA. I'm wondering if that's what Motif has done also - and the FDA want to have a look under the bonnet at the complete set of results.

"AbbVie has only presented top line data from the Phase 3 studies of elagolix in uterine fibroids and expects to present those data in full at an upcoming medical meeting. There was no mention by the company in any prior data releases for elagolix of liver function issues."

https://www.biopharmadive.com/news/fda-to-take-closer-look-at-liver-data-delaying-abbvies-elagolix/520993/

Will The BODS fundraise immediately. ...! How can they if they do not know what extent they will need to raise. WI'll they wait until FDA give specifics...how long will that take plus the fundraise. Does the company have enough cash to last until such a date that FDA set out what is required and fundraise us organised? Will we be told the specific details of what needs to be completed..before returning up mission. ...how long before the company need cash injection? Anyone care to guess which of these points will need to happen first....it surely depends on the extent and cost of what needs to be replaced submitted ...if a new trial then this will need far greater funding....it's a boT chicken and egg at the moment ...with a ticking clock for good measure.

Maybe more data needed here...not just a fixed dose.

"To date, iclaprim has been studied in over 1,400 patients and healthy volunteers. Clinical and microbiological data indicate that iclaprim has a targeted Gram-positive spectrum of activity, low propensity for resistance development and favourable tolerability profile. In clinical studies, iclaprim has been administered intravenously at a fixed dose with no dosage adjustment required in patients with renal impairment or in obese patients. The iclaprim fixed dose may, if approved, help reduce the resources required in hospitals since dosage adjustment by health care professionals is avoided and overall hospital treatment costs may be lower, especially in patients with renal impairment. Many standard of care Gram-positive antibiotics are not suitable for hospitalised ABSSSI patients with renal impairment due to efficacy and/or safety issues. "

It's interesting to note that last November the FDA specified the actual date for the result of the Motif application ...the date given was 13th Feb 2019 and even though the FDA recent troubles they were spot on. Therefore I think that puts any accusations of FDA foul play or kicking work down the road to sleep. The announcement was made on time.
https://globenewswire.com/news-release/2018/08/14/1551264/0/en/Motif-Bio-Announces-FDA-Acceptance-of-New-Drug-Application-with-Priority-Review-for-Iclaprim-for-Treatment-of-Acute-Bacterial-Skin-and-Skin-Structure-Infections.html

Don't expect the conference call to be anything other than positive.....it's about the only thing they can afford to do now to get some positivity out, that they can afford. Let's see what new information we garner , other than just generalisations.

Reading the RNS again ...Needing further data ...to evaluate toxicity....sort of jump out.....I would imagine Motif would have put the equivalent of the kitchen sink in their application ..in the way of every posative piece of data regarding low toxicity. ..but still some data either not presented clearly or not there at all...

It's hard to imagine that the data that is missing is sitting on someone's desk and had been forgotten to be included...I think the institutions probably know what they are doing and what the future holds ( at least until the raise and then the trial / data capture, then the application etc etc.
The catastrophic nature of the IIs response probably tells us more than the RNS...for now at least. Saying that if the science works then it will work again. ...sometime in the future ....its hard to imagine any more uncertainty at present....and there lies a risk and possibly a longer term reward. Gl

Just shows you, how unforgiving AIM is ...and how much even the most astute and researched investors ( let alone the actual company BODs) know .....even after such a drama we still know very little about what we are facing in 2019 and beyond...and that's the beauty of AIM...nothing is certain, only thing certain in AIM is that the company's that are listed will Need to raise money, on a regular basis.

It's all about what was in that FDA letter...and how expensive it will be to correct it.

More info here.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.110

Interesting read Crumbs. Thank you. I'm not sure if this blog has been posted but interesting to note some of the wide ranging present day side effects of IO treatment.

https://blog.aacr.org/what-are-the-side-effects-of-immunotherapies-and-how-do-they-arise/

"Never invest unless you ALREADY NOW what is going to happen".

"iNSIDER TRADING " is investing everything else is gambling.

" Buying Sales" I understand the advantage of the first two...but can you explain the third....thanks in advance.

Would expect CC to be in at least one of these....
https://m.economictimes.com/industry/telecom/telecom-news/vodafone-idea-aims-to-launch-narrowband-internet-of-things-in-1-year/articleshow/67858039.cms

Hi Stedon. If you found that interesting then wait till you read this one...:)
https://www.emis.com/php/company-profile/CN/Newcapec_Electronics_Co_Ltd__???????????__en_3303347.html