Member Info for spike912

Scott. Look mate, I’m not looking for an argument but I never lied as you all it. Please read my post Sunday 16:27. You are quite blatantly twisting words to your own agenda which is unfair and not on. I suggest you look at your own posts before twisting others. Any and all can see my 16:27 post and it’s blatantly obvious I did not say what you are claiming

Scot. I’m not deramping as you call it, simply stating my belief based on facts such as the RNS and the webcast you pointed me too. If anything it is you that’s being rather “choicey” over some of the words in the webcast used for example. But that’s not a dig just saying, people in glass houses I stated both sides of the argument on the trials (see my post Sunday 16:27), so not sure if your point Are you not also guessing? I believe so. Not sure why you feel that way as if you read my posts it’s far from deramping, in fact the total opposite in most cases

*asx

Yes I believe ask is open https://www.asx.com.au/about/asx-trading-calendar-2019.htm

Scot, ultimately we have to remember the CRL/FDA is a process. The meeting wasn’t particularly immediately, you need to look at the guidelines. Motif requested the meeting after the CRL was issued as standard practice. The FDA then have 30-45 days to meet....in fact it took from the issue of the CRL on the 14th Feb to the 3rd May (77 days) to meet...(less some time lag in requesting etc). Further data was indeed prepared from external third parties but it’s unusual to issue further data until the FDA Type A meeting, as that’s when you really find out why detail is needed. The CRL then Type A has little to do with the drug at times, it’s normally the process and right of the pharma to request the meeting which is normally granted unless the drug is a total flop I think your reading too much into things Scott.

Scott, just listened at they said “the fda were willing to do the meeting”, so be mindful, not picking on words but it’s very different to FDA “requesting” the meeting” I can see FDA issues around toxicity and have a feeling that they will want a further trial, given some within revive 2 had Hep A also. Whilst circa 3% on numbers seems a small trial. That said review questions were addressed with use of outside experts, so they seem well prepared. Interesting to see after NDA review no questions in CRL re efficacy, but seems surrounding around elevated liver levels. I don’t believe the FDA will just “change their mind”, both politically and clinically after putting this in the CRL. Currently no demand for additional trials according to webcast however. My feeling is the FDA is using a lower level of acceptance than motif potentially, and that’s the stumbling block. 3X upper limit is the marker, but none of the results from Iclaprim exceeded that.....which begs an interesting question....why deny the approval? CRL says liver toxins yet it appears within the 3X guidance. Motif also looked at 5X, which was again within FDA guidance levels I do think it very odd that they would not go into any detail on the CRL contents however. Interesting times.

What was the outcome of the repayment of loan notes at $7mil due 18th May? I know they were looking at the raise option but wasn’t this for “working capital”?

Thanks Scott

Will do Scott, have you got link? Wasn’t a dig buddy I just haven’t seen other video as yet :) so I was only going on the detail in the RNS

Whist a theory let’s not get carried away, it could be as simple as that period less drugs where suitable. If you compare other parts of the year you’ll see similar patterns. I guess it simply depends on what drugs are sent to the FDA in any given period. One month you could get a load of rubbish next month could be all superb. Luck of the draw. However I do think it will get to market, it’s just a case of sooner or later, play with caution at this stage for me. Ps....not trying to put dampener on things lol ;) just a cautious guy ;) Enjoy the bank holiday all and let’s keep fingers crossed for the next month

Scott, read the RNS of the 14th Feb “Bio plans to request a meeting with the FDA as soon as possible to discuss potential options to address the deficiencies.” The FDA didn’t request one, Bio did. The likelihood being the request after the CRL is a formality so I wouldn’t be reading anything into it. Given phase 3 trials, it would have been beat on impossible for a meeting to have been turned down so this was a simple and logical process procedure imo We thought 99% approved, then look what happened. In pharm nothing is 100%, even now, so my advise is never gamble more than you can afford to lose in pharm/bio plays However fingers crossed!

In reality I don’t see we will get a straight “yes” either way there will be something required, some form of delay, maybe small, maybe large but I think if it was a slam dunk, the US would have known I have a feeling it’s “ok” Ohhhh the excitement lol ;) Top up next week or don’t, that’s the million dollar question...been bitten so many times tho!

I think there’s remaining positive, and there’s throwing childish insults at fellow holders. We are all in the same boat, but insulting someone because they simply “post”, or if your not a “regular poster” doesn’t help anyone
Let’s keep it civil and continue to share/feed/debate off one another. Makes a much better board for commenting on, or even reading daily gleaning knowledge from those better advised
Remember...you don’t always have to post to care or be invested

PrivateRyan, they are more likely not wanting to spook the market either way until it’s “official”. I would imagine they wouldn’t risk telling the market anything until minutes are issued It appears there is a path forward but how and at what cost we will have to wait and see until it’s made official

Tsbs. What ever is that all about? I assume you’ve just had a bad day. I am terribly sorry for having an opinion. I also object to you questioning my holding, when if you took your hand of the keyboard for a second you’ll see I have posted in FRR for a number of years, maybe not as regular as some, but that doesn’t excuse getting on your high horse when someone simply makes a genuine comment on a DISCUSSION board. I get some may be sensitive at the moment but it costs nothing to show respect to fellow posters (genuine posters).

I don’t think many on here can say, after reading Hopes response, that it portrays FRR in any good light. It looks as if they have Zaza by the balls and it’s share incompetence over $2mil and a personal agenda taken us to this point. Hopes response (and whilst lawyers will always portray things in a light to suit their client), looks as if ZM and SN have made a right balls up and are trying to play for time to shuffle their own positions and fraudulent cash into a large safe with other shell companies. What is it they say...feels as if they are looking out for number 1. I really hope I am wrong, but reading Hopes response, it looks like a catalog of incompetent ******* ups

Reading Hopes response I have to say it does look as if we are well and truly fooked, all over $2mil. What utter clowns. I really hope they pull a rabbit out of the hat but it’s not looking good.
Anyone know when TRO is due to granted/denied?
If denied I assume that really is it and quick fire sale in a given?

12p higher lol can I have some of that!

Thras your wasting your time. They can’t even read I’m here lol, but keep asking where I am even tho I am posting lol

As I have always said, I’m transparent. You may not like what I post but I will always be transparent in my posts unlike some that have a clear ramping agenda Just as some of those ramping have likely to be have been quietly selling today or at the high 0.30s last week. But hey...that’s different isn’t it mmmm