Member Info for Tp23

Hi Ivy, I agree and also believe it is a labelling issue but as they say wtfdik? The EMEA described the initial results as having a narrow hepatic safety margin and raised the question of serious infections that may require treatment longer than the max 14 days used in the trials?? I would expect such questions would be dealt with with a black box liver warning?

Following Assist 1&2 the FDA issued a CRL not passing Iclaprim yet on this occasion they have issued a letter requesting more information? The interesting read is the withdrawal letter for Iclaprim from its submission to the EMEA in 2009 where liver toxicity issues wee identified which, I believe resulted in the am ending of the dosing regime? The EMEA did ask further questions which I would have expected the company and Covance to have taken on board and it may be these areas that the FDA seek clarification of? It’s interesting to see that the EMEA still had Iclaprim on their radar:
https://www.ema.europa.eu/documents/agenda/agenda-pdco-agenda-21-24-august-2018-meeting_en.pdf#page37

For those interested FDA guidance notes published in 2009
https://www.fda.gov/downloads/guidances/UCM174090.pdf

Ryan, many thanks have now found it.

Guys, sadly I missed the Conf call today, did they say if the call was being recorded and if it was going to be published?

Ivy I agree, following the Assist studies the dose was amended to 80mg 2hrs evry 12 and to 40mg for people with moderate hepatic impairment? We don’t know how many of the sub set (moderate hepatic impairment) were treated with the lower dose and what claim for the label was made?

Jimzi, subjective interpretation and conjecture on my behalf until we have more detail from the company. It could be that the sample size is insufficient re liver toxicity ie no evidence of liver toxicity as opposed to evidence of no liver toxicity?

Ivy I agree, need more data to be published?

As Ivy and Ian have stated it would be difficult to assume or analyse anything until we know more details of specific data eg dosing 80mg or 40 mg etc and, what the company was applying for on the label?

From the Phase 3 safety results: Eleven (3.7%) patients in the iclaprim group and nine (3.0%) patients in the vancomycin group had increases in alanine aminotransferase or aspartate aminotransferase levels to >3 times the upper limit of normal (ULN) during treatment. Three patients (one in the iclaprim group and two in the vancomycin group) had a diagnosis of acute hepatitis A confirmed by IgM serology. Two of those patients (one in the iclaprim group and one in the vancomycin group) had bilirubin level increases of >2 times the ULN. These increases resolved to baseline values upon discontinuation of the drug in all patients. No subject in this study met Hy's law criteria.

Hi Ivy, is the twitter group active and if so could you add me please?
Thanks, TP23

Hi Hanibal, I stand to be corrected but I believe Iclaprims USP claim is no side effects on renal impairments only not liver?

Hi Ivy,
Have they released figures of how many patients during the Revive studies were identified as having moderate hepatic impairment and administered with the 40mg dose? I note they have identified 12 patients as having increased AST levels but the chart does note identify how many were treated with the lower dose?

I hope the rig mobilises soon as the Field Licence runs out on the 1st May if the field has not been 'developed' by that date!!

Am a bit confused? in the Q&A point 17 AP is asked when the new trucks will arrive and states that this introduces a financial burden in the form of lease payments?
I thought the trucks had been purchased and paid for? As per shareholder Q&A dated 6/9/2018 - point 6: The money to finance the new equipment was raised at the end of June so we expect deliveries to commence in early 2019?? so where has that money gone??

TPT,
I really don’t see what your point is? I know that plans can change and that other ‘things’ can be done? The point I raised was simply to express that a near term fund raise should the BOD receive sufficient votes was a high probability! I did not state that was a negative thing or a positive thing only that it was a possibility inferred by the BOD!

TPT, I’m sure there are ways of isolating water ingress, I am just reiterating what the BOD stated in the RNS as a likely requirement for near term funding!

TPT, The Notice of General Meeting RNS indicated that the revenue from the wells was declining and will continue to do so unless they are reworked? It also mentions that “In the short term and independent of permitting and subject to funding, the Company could seek to increase current production through a workover of Pg-11A to isolate and seal off the source of formation water and by the installation of compression equipment to prolong the life of Pg-10” I think that if the BOD receive the requisite votes then a raise would soon follow?
I would like to hear the outcome of the visit with the Minister before a vote and would also like to have a little more information re the SR?

Apologies if I’m asking something obvious but can anyone tell me how many shares the BOD are requesting to be able to issue if they need to? And, what % dilution that would be to the current shares in issue?

Can anyone explain the large buy at 08:43hrs of 5.25m shares for 46.94k. The buy is not showing on the HL list of trades but is on the Stock Exchange list with a Trade Flag LRGS?