friend of mine got in touch via text the night before last and wanted a one line sentence, a super executive summary of how the interview went....in fact ...he wanted the whole hour long interview summarised in just one word!
What was the word we could ascribe that summarised the more than one hour long interview covering many points and questions and that would encapsulate the mood of Mr X in terms of the current situation we have with our IND and our possible future pathway?
"POSITIVE"
...was the single word that summarised it.
ACKNOWLEDGMENTS
Big thanks to Axelrod who again who put a lot of effort in for this to take place. It is through beaut contacts through our PAR HC that we as a team can achieve so much. Support each other for the betterment of not just our forum...but for the increased knowledge, awareness and of course to make some cash for US.
Thanks to those that asked questions, always great to get a wider variety of questions and feedback.
Not unlike PAR's professionalism and their LONG term thinking, we too should also strive for better knowledge, thinking outside and much beyond the square and develop a deeper understanding and questioning of what we actually own. After all, we as shareholders have a stake in the company.
CAVEATS
I have tried my best to capture MR X's intentions in his answering of the questions. Mr X himself has only a cursory high level knowledge of Paradigm specifically. Full disclosure, to my knowledge he has little to no shares of PAR (I believe it is the latter). He knows of the company and what they are going after but in no way does he claim to be an expert in the actual field of OA or have any necessarily specific and detailed knowledge of PAR. In a way, I find that to be a bonus of sorts for us as his inherent bias is low to nil.
Any statements and quotations below are not advice and you must formulate your own opinions. All investments contain risk, seek your own personal licensed financial advisor if you need advice.
THE INTERVIEW...
Originally we anticipated we'd spend about 20 to 30 mins on the interview but there was slim to no chance of us being able to stick to that, it was awesome hearing his thoughts, his answers and background that he gave us as to what to expect and a little on how it works. In the same vein I thought I might be able to put it all into one post, no chance, I'll spread it over two parts. See the end of Part 2 for footnotes.
As per usual, please enjoy.
PART 1
BACKGROUND
Mr X as we will call him to keep him anonymous, in my opinion, is the height of experience and professionalism. He was courteous, has a friendly disposition and mate, knowledgeable with a large amount of experience in the field. On top of those merits and traits, he actually even gave us a couple of tips...I've included these in Part 2.
With the experience of some 400 trials and submissions spanning multiple areas of therapies along with some 18 years plus in the industry, this guy is a wealth of knowledge and experience in this domain. It was a real pleasure to talk with him on your behalf. Let's get to down to the questions and answers:
QUESTIONS/ANSWERS
QUESTION 1. Have you seen or heard of evidence yourself of drug applications being unusually delayed at the FDA at present due to Covid workloads?
During Covid times companies in the BioPharma space have had to be more proactive.Companies operating in this field have had to find new ways to transact.The FDA have basically responded by saying they have an increased workload (evidenced also by a quick chat about how other companies in the Bio space are also currently getting feedback that there are delays).
Mr X's exact words where "They are busy, that doesn't surprise me". Mr X also went on to say that companies putting in submissions particularly in the last year, have had to adapt and take on new tech such as the Zoom meetings and little to no ability for physical trips and meetings that otherwise would have taken place.
Different countries have had different rates of Covids at various stages, this all impacted the FDA's work load to account for data and statistics due to varying levels of drop outs. In some cases additional work needed to be done to cater for this, all this added additional workload along with the obvious physical restrictions imposed on the FDA themselves due to Covid.
Mr X at this point turned the interview back on us to ascertain more information, he asked us questions such as:
"Do you have any evidence of what mitigation effects Paradigm has undertaken?".
I answered by covering things such as:
- Increased clinical sites (65 of them) to reduce risk.
- Ability for clinicians to go to the patient (home visits) instead of making the patients go into the clinic or a hospital.
- Increasing numbers of patients to escalate coverage of potential drop out numbers due to Covid illness during the trials.
Mr X on several occasions reassured us that it seemed like it was more of an administrative type delay as opposed to anything more concerning (His opinions). He expressly stated " The FDA are pretty swamped at the moment" and "they have directed a bunch of their resources through to Covid [related treatments]". Even though the panel themselves may not be lower in number, it will be all the support staff, from the "Typing pool" though to "Reg" teams.
Mr X also commented that a meeting could always be held after the IND to discuss things that the FDA might want to raise as long as they were not showstoppers in terms of what has been submitted. He seemed to suggest that if anything was really lacking or concerning it would have been raised at an earlier stage...this gave him an extra degree of confidence that all was ok and was part and parcel of the extra required time.
QUESTION 2. We are trying to get a sense for how long the IND application might remain on hold and when the IND might open. We believe that once the FDA provide questions to the company and the company responds to such questions the 30 calendar day window restarts. Does the FDA typically try to bundle all questions to the sponsor in one round or can there be multiple rounds of questions?
In this case Mr X confidently answered that the FDA would bundle all or as many questions in the one hit. They would not trickle them out over time causing potentially months of further delays.
It was also asked if the newness of the company ie PAR has not submitted an IND before (not including EMA program) would at all have any bearing on how the FDA approaches such a company, he answered by saying that that has no bearing at all. As long as the submission itself follows all the predesignated formats and structure and covers all the required material, that's what was important.
Again Mr X alluded to how busy the FDA are at the moment especially in light of all the new Covid applications and testing that has and is, occurring.
QUESTION 3. There is some evidence that the drug to be trialed often causes a temporary benign rash at the injection site. There has been some external suggestion that this could potentially compromise the double blinding aspect of the Phase 3 trial given that it will be known to some people (both administering and participants) as to whether they are receiving the placebo or actual drug. Surely this sort of minor AE occurs regularly in drug trials. Based on your experience what is the FDA's likely view? Would the trial design need to be tweaked to ensure blinding is not compromised?
In this area Mr X chatted about some of the types of non clinical data including, but not limited to in vitro studies (Mozz note: means outside the body), manufacturing process and preparation for the same along with formulation information of the drug. Mr X then went on to state that Non clinical data can pertain to regulatory information but usually involved the manufacturing and even transport and storage processes.
In terms of the whole issue of rashes/site AE's he commented that his experience led to his belief that subcutaneous (Mozz note: means under the skin) injections does often result in minor rashes. He said it would depend on how common it is and the timing of the same. Interestingly Mr X said in all his experience he had not come across any company that had to employ a strategy to mitigate what was called "Functional unblinding".1 Ie taking into consideration an obvious effect as a result of the real drug compared to lack there of in the placebo cohort.
Further, he suggested it will depend on the qualitative nature of this observation and whether there are after effects which will be studied in the trial. He also suggested that a choice of an injection site might also be an option to mitigate this sort of side effect or at least observation of the same. (Mozz note: generally there are three sites iPPS can be administered in, Stomach, Thighs and Buttocks).
That concludes Part 1.
In Part 2 we tackle additional questions and as a bonus we will cover some tips that Mr X gave us.
(20min delay)