Member Info for bignose58

Heimdal, you are back. I wondered what had happened to you.

So, you are looking for a new job, which is understandable given what’s going on in HK, however. Just remember, the DLI won’t pay very well since they have no income with which to pay you and I would suspect, currently, any money ERP has is needed to get Fortacin across the line in the good ol US of A which cannot be that far off now.

The volume has certainly picked up these last few days and we still have several to go before the results. I cannot help feel, given this renewed interest, that some positive news is going to be forthcoming. Some are even willing to pay well over the odds for just a handful of shares. Surely a leak on content ??? Yes, I do realise that some gamblers just jump on a rise, but given the slow consistent decline it doesn't really make sense to do so unless some news is known or anticipated.

Also, I have been thinking. Given that the US has its own manufacturer (Catalent Pharma Solutions, LLC) and currently all other licenses point to PSNW as their supplier, who, as we know, are making a real pigs ear out of a consistent supply. Surely the company should start investigating other sources to cope with a projected demand ??? Of course that isn't to say that the current agreements only point to PSNW for supply of study amounts and commercial requirements may be met by more local suppliers. however. Since there have been some attempts at upscaling which may be considered to negate my speculation, I still think they wont be able to keep up with demand and other local more logistically strategic sources need to be considered ???

HS ended at 7% up whilst ERP are 1.8% down. It drops on negative sentiment and drops on positive sentiment…..lol

They just need enough spongdoolies to get the NDA submitted, then, I’m sure the gloves will be off. As far as I’m concerned, the FDA will approve of the product since they have been involved to some extent since 2014 and would have surely had some comments along the way. The initial EU sales and the recent OTC approval cannot be ignored.

Main market up 5.5% and we are down 4.5% on no change in volume. WTF !!!

Main market up 4.5%, ERP down 3.5% ,as I write, on next to no volume. :-) manipulation at its best……lol

Up 8.5% as I write today. Yet we've only managed 2.7%. It jumped 17% first thing and then plunged into the red. I'm no expert, but there certainly appears to be some manipulation by the MM's going on. To what ends, I don't know, but they must have a lot of shares which they have bought over the past few weeks and they don't seem to be offloading any given buys have been nearly equal to sells these last few days (as it should be).

Any other views about the sudden changes in price that have been taking place?

I’m pretty sure the operational update is going to be quite positive given the largish buys recently (possible leaked information ?). Whoever sold that 1.7mill yesterday will, I’m sure, be kicking him/herself for the rest of the year.

Onwards and upwards (the only direction it can go now)….although, as we well know, “anything can happen in the next half hour.”. :-)

Anyway, I’m sure things will start looking up here now once we know of the FDA outcome which I expect shouldn’t be an issue.

Not surprising given what’s happened since with the China syndrome and current c19 no tolerance futility.

And although the main markets were down over 5%, you can bet that when they pick up by a similar amount, this will not follow suit.

Certainly strange, Why didn't they all sell a week ago instead of waiting for it to drop another 25% over the last several days.

Just look at the last 2 trades both buys and each only for a single lot about 110 and 124 squid yet nearly 13% difference in price. Certainly some M&M shenanigan's going on.

Well hat sailed through without objection, just like normal.

Strange SP movement today. Started off in the red, only to suddenly jump to +6% in the afternoon and then suddenly drop off again to -8% finally ending at just over -4%. Some payed as much as 0.138 only to see a loss of 20% by the end of the day. I wouldn't be surprised if those that bought in at that magnitude of sp were then caught out with their own stop losses...... Ce la vie.

I wonder how low it will be massaged down before any decent news is released ?

And China would have been approved too.

We lost a year because the numpty's Didn't bother to check the authorities had all the paperwork.

That said. Rest assured as each week passes by, the light is forever becoming clearer at the end of the tunnel.... ;-)

Dougie, I would suspect they are direct from the horses mouths, however. If it really had been all under control with Jamie and Jim, we would have had an upfront payment from Israel and the FDA approval would have happened a couple of years back instead of us all still sitting here waiting twiddling our thumbs as well as twiddling other things......lol

Stating the obvious, volume has increased the last couple of days.

Although it hasn't usually increased before recent results, I suspect this could be what's driving this now with the expectation of confirmation of the start of the China study and the result/possible start of the US phase III. Not so much impact on the sp since it would seem some pi's are still wanting to exit after giving up. :-).

Results could be an interesting read. Onwards and dare I write upwards (silence that man)...lol

Of course, that doesn't include for a possible license agreement which I would suspect could land after the said meetings and a clear way forward with the Phase III is given a green light by the FDA.

Just a reminder, lest we forget. In March 2014 a PLE announcement (RNS Number : 9983B) was made stating:
Plethora (AIM: PLE) is pleased to inform shareholders that our recent meeting during Q1 2014 with the United States Food and Drug Administration ("FDA") has now unambiguously defined the path to a successful submission of the New Drug Application.

Shareholders have still not been given any update/clarification as to why there is now ambiguity, since the current way forward appears to make a change in tack and obviously to the FDA agreed path to the "successful submission". It certainly begs the question as to whether the RNS content at the time was written to mislead the markets. Particularly since the phase II results have been stated as being excellent and more than supportive of the EU results which were available when the announcement was made.

Just to expand on Bothwells long and informative last post....lol.

According to the 2021 mid year results it was stated that:
On the assumption that the phase II trial is sufficient to convince the FDA that the PEBEQTM serves as an appropriate measure for support of a label claim, the pivotal Phase III study could commence in the latter half of 2021, with NDA submission possible in late 2022, giving a PDUFA date at the end of 2023, however, since they changed tack and, as we all know, the study did not commence.

The latest information provided in the 14th Dec 2021 announcement included:
The Company’s CRO has requested a RLD Type C meeting with the FDA for the purposes of obtaining feedback
from the division on the RLD protocol before the EOP2 meeting, which the Company anticipates in 1Q 2022. At the EOP2 meeting the Company will be seeking FDA agreement with PEBEQ as the endpoint, concurrence on the protocol of the Phase III study and agreement on the RLD study. It is anticipated that although timelines have been extended since the Company’s last Shareholders’ update, using a streamlined adaptive clinical trial design the previously projected timelines are attainable.

So, it would appear they are still intent on a PDUFA date at the end of 2023. Although any future update on the results of the said meetings could put the kybosh on that.

Although the SP has dropped off a cliff....

:-O