Protalix stock has continued to lose altitude in recent days, after receiving a referral from the FDA for clarification on their latest clinical trials. What is the result of the decline in the share price? There are two rational reasons: the increase in risk, and the extension of time to market that pushes for alternative investment. However, there is another, emotional reason – the disappointment of investors who expected to receive full approval of the drug in this response. An examination of the factual basis for the existence of rational reasons will leave us in my opinion mainly with the emotional reason. Therefore, I anticipate an interesting opportunity to collect Protalix shares at an attractive price.
plant protein
In the hearts of quite a few drugs stands some protein. While for research it is possible to produce proteins of their origin in nature, for the purpose of industrial production they must be produced commercially. For this purpose, the protein production systems of laboratory bacteria are "taken over", causing them to produce the requested protein. Protalix has developed a system for the production of proteins in plants, giving it an advantage over normal production methods.
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With this system, the company strives to replicate (Biosimilar) recognized and proven drugs, which reduces the risk involved in its activities. The company's flagship product is a cure for Gaucher's disease. According to the company's publications, approximately 5,000 patients with the disease were treated in the U.S. alone in 2006, at a cost of $200,000 per patient (do the math), and there is currently only one similar product on the market to treat the disease.
WHAT DID THE FDA WANT?
Protalix tested the company's flagship product in the third phase of clinical trials required by the FDA. On the basis of the successful trial results according to its publications, the company submitted an application in December 2009 for approval of the marketing of the drug (NDA). In the agency's response, she asked for explanations on two issues. The first is supplementary information about the two experiments submitted by Protalix. In order to understand the meaning from the company's point of view, it is necessary to understand that experiments consist of three stages: planning, execution, and analysis of the information received. The most expensive and prolonged stage is execution, whereas in order to analyze the data you usually only need a computer...
The clarifications demanded by the Authority, according to the company's publications, require further analysis of the data only. Therefore, the time and funding required to carry them out are relatively small compared to the experiments. Estimated time varies but is estimated in months to years. This depends on whether Protalix submits a Class 1 class of 1 that is shorter (around 3 months) or type 2 (over six months). In addition, Protex had $35 million in its coffers earlier this year, which should make it through the year. The second issue mentioned in the agency's Complete Response Letter touched on the production processes.
However, according to the company's publications on its Form10K, the Authority had already requested clarifications regarding the production processes as early as January 2010, and following the clarifications sent by the company, the agency approved the finality of the company's marketing approval application. It is not clear, therefore, why the agency requires additional clarifications at this stage, but it can be assumed that they are not significant (concerning unevenness between production series, etc.) but more minor (tightening supervision, additional quality checks, etc.). In addition, the 10K indicates that the Israeli Ministry of Health audited the company's facilities and found that they met the strict GMP production standard. This point contributes to the assessment that the time to reach the market will not be significantly longer.
other things to think about
in November 2009, the company signed a strategic agreement with pharmaceutical giant Pfizer to develop and market the product worldwide, except in Israel. the company is expected to receive 40% of the revenue derived from the sales of the product, as well as revenue from its sale in Israel. in addition, the agreement included an investment of tens of millions of dollars in protein, and additional investments as the company progresses in the process of approving the company. please note that this means a risk of dilution of shares for investors in the long term. however, this is an impressive expression of trust on the part of the pharmaceutical giant, which will ensure financing for the company's future operations and make Pfizer's massive marketing and distribution system available to prolix. in addition, a request has been submitted for approval of marketing in Europe.
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Often this perception is referred to as a ”place” existing in a consumer’s mind.
A positioning statement is meant to navigate business decisions and incorporate its purpose.However, markets are dynamic, continuously changing with new competitors, developing with consumer needs, innovations in technology, government laws, and economic circumstances, among other elements such as a worldwide pandemic.
This is why it is critical for companies to reconsider their positioning right after the market shifts or they are risking being left behind.In the face of such a gigantic market shift, a lot of companies have been reanalyzing their position and how they can adapt and withstand.
It involved identifying your target audience, examining their problems, and then outlining how your products or services can resolve their pain points better than your competitors and explaining why consumers should believe that.However, it is vital to ask your audience to find out this information instead of presuming on their behalf.
This will let you find some gaps in the map that represent an opportunity for a unique position called ”white space” in the market.Contrary to the time when you first established your positioning, repositioning should consider your starting point because you are not starting from scratch, and your customers already have developed a perception about your company.
The more you move away from what your business is known for, the more time, effort, and resources will be required.
